Coulter Electronics, Inc.: FDA clearances and approvals
Coulter Electronics, Inc. has 101 FDA 510(k) clearances (first 1976, latest 1994), across 49 product codes in 6 review panels. Median 510(k) review time: 53 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GKL | Counter, Cell, Automated (Particle Counter) | 17 | 17 |
| GKZ | Counter, Differential Cell | 14 | 14 |
| JPK | Mixture, Hematology Quality Control | 8 | 8 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 4 | 4 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 4 | 4 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 3 | 3 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 3 | 3 |
| KRY | Calibrator For Platelet Counting | 3 | 3 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 2 | 2 |
| CIJ | Saccharogenic, Amylase | 2 | 2 |
Plus 39 more product codes.
Review panels
- Hematology (48)
- Clinical Chemistry (43)
- Clinical Toxicology (5)
- Dental (1)
- Immunology (1)
- Pathology (1)
Most recent Coulter Electronics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K923951 | CD8 CYTOSPHERES KIT | MAM | 1994-04-25 | 627 |
| K930119 | COULTER RETIC-C CELL CONTROL | JPK | 1993-04-05 | 83 |
| K921279 | CD4 CYTOSPHERES KIT | GKZ | 1992-12-29 | 287 |
| K923530 | COULTER MULTI-Q-PREP | GKH | 1992-10-14 | 90 |
| K922181 | COULTER MH009 | GKZ | 1992-08-17 | 101 |
| K922704 | COULTER MAXM W/ AUTOLOADER | GKZ | 1992-07-27 | 52 |
| K921567 | COULTER MH017 | GKZ | 1992-07-06 | 95 |
| K912133 | PX COULTER(R) CELL CONTROL | JPK | 1991-07-17 | 64 |
| K911385 | COULTER(R) MH010 | GKZ | 1991-06-17 | 81 |
| K905771 | COULTER DART AST (GOT) REAGENT | CIT | 1991-02-26 | 61 |
91 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Coulter Electronics, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Coulter Electronics, Inc. have?
Coulter Electronics, Inc. has 101 FDA 510(k) clearances (first 1976, latest 1994), across 49 product codes in 6 review panels.
How long does FDA take to clear Coulter Electronics, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Coulter Electronics, Inc.'s cleared 510(k)s is 53 days.
What devices does Coulter Electronics, Inc. make?
Its most frequent FDA product codes are GKL (Counter, Cell, Automated (Particle Counter), 17); GKZ (Counter, Differential Cell, 14); JPK (Mixture, Hematology Quality Control, 8).
Has Coulter Electronics, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Coulter Electronics, Inc. Related entities may recall under other names.
Next steps
- See all 101 Coulter Electronics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GKL, Coulter Electronics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.