Medical device manufacturer
Abbott Laboratories, Inc.
Abbott Laboratories, Inc. holds 889 FDA 510(k) clearances across 268 product codes. Median elapsed review time is 61 days. openFDA lists 267 recall records naming the company. FDA publishes it under 10 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 889
- Product codes
- 268
- Median review
- 61 days
- Recall records
- 267
How does FDA spell Abbott Laboratories, Inc.?
FDA publishes this company under 10 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.
| As FDA published it | Dataset | Matched by |
|---|---|---|
| ABBOTT LABORATORIES | device/registrationlisting | normalised |
| Abbott Laboratories | device/510k | normalised |
| Abbott Laboratories | device/recall | normalised |
| Abbott Laboratories | device/enforcement | normalised |
| Abbott Laboratories Inc. | device/recall | normalised |
| Abbott Laboratories, Inc | device/enforcement | normalised |
| Abbott Laboratories, Inc | device/recall | normalised |
| Abbott Laboratories, Inc. | device/enforcement | normalised |
Showing 8 of 10.
Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.
Which product codes does Abbott Laboratories, Inc. file in?
268 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| FRN | Pump, Infusion | 67 | 81 days | |
| FPA | Set, Administration, Intravascular | 30 | 59 days | |
| GKZ | Counter, Differential Cell | 24 | 81 days | |
| KNT | Tubes, Gastrointestinal (And Accessories) | 23 | 153 days | |
| CIG | Diazo Colorimetry, Bilirubin | 15 | 58 days | |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 15 | 50 days | |
| CDP | Radioimmunoassay, Total Triiodothyronine | 13 | 52 days | |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 13 | 53 days | |
| LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 12 | 162 days | |
| NBW | System, Test, Blood Glucose, Over The Counter | 12 | 95 days | |
| FPB | Filter, Infusion Line | 11 | 57 days | |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 10 | 52 days | |
| LJC | Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) | 10 | 87 days | |
| DQO | Catheter, Intravascular, Diagnostic | 9 | 94 days | |
| GTZ | Antisera, All Groups, Streptococcus Spp. | 9 | 88 days | |
| CEC | Radioimmunoassay, Free Thyroxine | 8 | 45 days | |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 8 | 40 days | |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 8 | 33 days | |
| DKZ | Enzyme Immunoassay, Amphetamine | 8 | 51 days | |
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 8 | 63 days | |
| JXM | Enzyme Immunoassay, Benzodiazepine | 8 | 56 days | |
| LDJ | Enzyme Immunoassay, Cannabinoids | 8 | 47 days | |
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 8 | 242 days | |
| DIS | Enzyme Immunoassay, Barbiturate | 7 | 57 days | |
| KDJ | Set, Administration, For Peritoneal Dialysis, Disposable | 7 | 64 days |
Showing the 25 they file in most, of 268.
Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.
Source: openFDA device/510k · retrieved
Has Abbott Laboratories, Inc. had a recall?
openFDA lists 267 recall records naming this company across its whole history, of which 2 were opened in the last 12 months and are not yet marked terminated. A recall record covers one firm's corrective action and may span many device lots.
Z-0961-2026Class IIOpen, ClassifiedJJE
Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the recall is potential performance issues found in the Alinity ci-series System software versions 3.6.1. and lower that could lead to erroneous results for multiple analytes. The issue was identified by Abbott during the internal testing of complaint investigations.
Z-0489-2026Class IIOpen, ClassifiedGKZ
Software issue for hq analyzer results in system not visibly applying appropriate flagging to results when saturation is present which may result in incorrect results.
Z-1652-2025Class IIOpen, ClassifiedGKZ
When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.
Z-1653-2025Class IIOpen, ClassifiedGKZ
When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.
Z-1654-2025Class IIOpen, ClassifiedGKZ
When expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user that an expired reagent is being used. Use of expired reagents is against the guidelines of the Operator's Manual.
Showing the 5 most recently initiated of 267.
Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.
Source: openFDA device/recall · retrieved
What has Abbott Laboratories, Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K252424 | Anti-HCV Next | MZO | 270 | |
| K243500 | ARCHITECT iGentamicin | LCD | 239 | |
| K243168 | Alinity i Rubella IgG | LFX | 263 | |
| K243283 | Alinity h-series System | GKZ | 126 | |
| K233932 | Alinity i Toxo IgM | LGD | 260 | |
| K232669 | TBI | QAT | 28 | |
| K222850 | HAVAb IgG II | LOL | 323 | |
| K220031 | Alinity h-series System | GKZ | 576 | |
| K220282 | i-STAT PTplus Cartridge with the i-STAT 1 System | GJS | 528 | |
| K230937 | Alinity i Total ß-hCG Reagent Kit, GLP systems Track | DHA | 63 |
Source: openFDA device/510k · retrieved
Where is Abbott Laboratories, Inc. registered?
FDA lists 5 registered establishments for this company in US.
Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.
Watch what Abbott Laboratories, Inc. files next
Get an email when this company clears a new device, or when anything is recalled in a product code you follow.
Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.