Medical device manufacturer
Acon Laboratories, Inc.
Acon Laboratories, Inc. holds 93 FDA 510(k) clearances across 39 product codes. Median elapsed review time is 78 days. openFDA lists 1 recall record naming the company. FDA publishes it under 6 different spellings, all counted here as one company.
Updated · ingest status · JSON
- 510(k) clearances
- 93
- Product codes
- 39
- Median review
- 78 days
- Recall records
- 1
How does FDA spell Acon Laboratories, Inc.?
FDA publishes this company under 6 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 |
|---|---|---|
| ACON LABORATORIES, INC. | device/registrationlisting | normalised |
| ACON Laboratories, Inc. | device/510k | normalised |
| Acon Laboratories | device/510k | normalised |
| Acon Laboratories Co. | device/510k | normalised |
| Acon Laboratories, Inc. | device/enforcement | normalised |
| Acon Laboratories, Inc. | device/recall | normalised |
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 Acon Laboratories, Inc. file in?
39 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| NBW | System, Test, Blood Glucose, Over The Counter | 13 | 90 days | |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 10 | 53 days | |
| DJG | Enzyme Immunoassay, Opiates | 6 | 67 days | |
| DKZ | Enzyme Immunoassay, Amphetamine | 6 | 69 days | |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 5 | 50 days | |
| GTY | Antigens, All Groups, Streptococcus Spp. | 4 | 69 days | |
| LDJ | Enzyme Immunoassay, Cannabinoids | 4 | 63 days | |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 3 | 110 days | |
| DIS | Enzyme Immunoassay, Barbiturate | 3 | 70 days | |
| LAF | Gas Chromatography, Methamphetamine | 3 | 62 days | |
| SCA | Multi-Analyte Respiratory Virus Antigen Detection Test | 3 | 89 days | |
| CGA | Glucose Oxidase, Glucose | 2 | 127 days | |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 2 | 30 days | |
| FLL | Continuous Measurement Thermometer | 2 | 53 days | |
| KQO | Automated Urinalysis System | 2 | 118 days | |
| QYT | Over-The-Counter Covid-19 Antigen Test | 2 | 200 days | |
| CDM | Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | 1 | 67 days | |
| CEP | Radioimmunoassay, Luteinizing Hormone | 1 | 37 days | |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 | 44 days | |
| DIC | Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method | 1 | 231 days | |
| DJR | Enzyme Immunoassay, Methadone | 1 | 66 days | |
| DJZ | Devices, Breath Trapping, Alcohol | 1 | 115 days | |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 1 | 35 days | |
| FMK | Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | 1 | 156 days | |
| GKR | System, Hemoglobin, Automated | 1 | 349 days |
Showing the 25 they file in most, of 39.
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 Acon Laboratories, Inc. had a recall?
openFDA lists 1 recall record naming this company across its whole history. A recall record covers one firm's corrective action and may span many device lots.
Z-2322-2015Class IIITerminatedDJZ
Acon Laboratories, Inc. is recalling Mission Breath Alcohol Detector due to a labeling amendment.
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 Acon Laboratories, Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K261212 | Flowflex Plus RSV + Flu A/B + COVID Rapid Test | SCA | 87 | |
| K251697 | Flowflex® Plus Strep A Rapid Test Cassette; Flowflex® Plus Strep A Rapid Test Strip | GTY | 177 | |
| K251749 | Flowflex Plus RSV + Flu A/B + COVID Home Test | SCA | 138 | |
| K250085 | On Call® Sure GK Blood Glucose & Ketone Monitoring System; On Call® Sure Sync GK Blood Glucose & Ketone Monitoring System | NBW | 270 | |
| K250377 | Flowflex Plus COVID-19 + Flu A/B Home Test | SCA | 89 | |
| K232715 | Distinct® Digital Pregnancy Test | LCX | 269 | |
| K233373 | Flowflex® Plus COVID-19 Home Test | QYT | 200 | |
| K230828 | Flowflex COVID-19 Antigen Home Test | QYT | 227 | |
| K193318 | Distinct® Early Detection Pregnancy Test | LCX | 262 | |
| K192175 | On Call Express II Blood Glucose Monitoring System | NBW | 66 |
Source: openFDA device/510k · retrieved
Where is Acon Laboratories, Inc. registered?
FDA lists 1 registered establishment 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 Acon Laboratories, Inc. files next
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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.