Medical device manufacturer
Coulter Electronics, Inc.
Coulter Electronics, Inc. holds 101 FDA 510(k) clearances across 48 product codes. Median elapsed review time is 53 days. openFDA lists no recall records naming the company.
Updated · ingest status · JSON
- 510(k) clearances
- 101
- Product codes
- 48
- Median review
- 53 days
- Recall records
- 0
How does FDA spell Coulter Electronics, Inc.?
FDA publishes this company under a single spelling, so nothing needed merging here. Many manufacturers are not so tidy.
Which product codes does Coulter Electronics, Inc. file in?
48 product codes, ranked by how much they file in each.
| Code | Device | Clearances | Median review | Latest |
|---|---|---|---|---|
| GKL | Counter, Cell, Automated (Particle Counter) | 17 | 50 days | |
| GKZ | Counter, Differential Cell | 14 | 73 days | |
| JPK | Mixture, Hematology Quality Control | 8 | 64 days | |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 4 | 55 days | |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 4 | 29 days | |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 3 | 34 days | |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 3 | 22 days | |
| KRY | Calibrator For Platelet Counting | 3 | 96 days | |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 2 | 42 days | |
| CIJ | Saccharogenic, Amylase | 2 | 38 days | |
| JHT | Chromatographic Separation, Cpk Isoenzymes | 2 | 45 days | |
| CDN | Urease, Photometric, Urea Nitrogen | 1 | 31 days | |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 | 91 days | |
| CDX | Radioimmunoassay, Total Thyroxine | 1 | 42 days | |
| CEK | Biuret (Colorimetric), Total Protein | 1 | 57 days | |
| CEM | Electrode, Ion Specific, Potassium | 1 | 56 days | |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 1 | 71 days | |
| CFM | Bathophenanthroline, Colorimetry, Iron (Non-Heme) | 1 | 18 days | |
| CFR | Hexokinase, Glucose | 1 | 71 days | |
| CHJ | Mercuric Thiocyanate, Colorimetry, Chloride | 1 | 53 days | |
| CIG | Diazo Colorimetry, Bilirubin | 1 | 12 days | |
| DEW | Igg, Antigen, Antiserum, Control | 1 | 90 days | |
| DKZ | Enzyme Immunoassay, Amphetamine | 1 | 28 days | |
| EKZ | Unit, Electrosurgical, And Accessories, Dental | 1 | 95 days | |
| GIF | Diluent, Blood Cell | 1 | 66 days |
Showing the 25 they file in most, of 48.
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 Coulter Electronics, Inc. had a recall?
openFDA lists no recall records naming this company. That is the absence of a record, not a guarantee — and it counts only recalls FDA has published under a spelling we resolved to this company.
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 Coulter Electronics, Inc. cleared recently?
| 510(k) | Device | Code | Decision | Elapsed days |
|---|---|---|---|---|
| K923951 | CD8 CYTOSPHERES KIT | MAM | 627 | |
| K930119 | COULTER RETIC-C CELL CONTROL | JPK | 83 | |
| K921279 | CD4 CYTOSPHERES KIT | GKZ | 287 | |
| K923530 | COULTER MULTI-Q-PREP | GKH | 90 | |
| K922181 | COULTER MH009 | GKZ | 101 | |
| K922704 | COULTER MAXM W/ AUTOLOADER | GKZ | 52 | |
| K921567 | COULTER MH017 | GKZ | 95 | |
| K912133 | PX COULTER(R) CELL CONTROL | JPK | 64 | |
| K911385 | COULTER(R) MH010 | GKZ | 81 | |
| K905771 | COULTER DART AST (GOT) REAGENT | CIT | 61 |
Source: openFDA device/510k · retrieved
Watch what Coulter Electronics, 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.