Coulter Corp.: FDA filings under this applicant name
FDA lists 51 510(k) clearances under the applicant name “Coulter Corp.” (first 1989, latest 2000), across 21 product codes in 3 review panels. Median 510(k) review time under this name: 83 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Danaher (Beckman Coulter, Leica Biosystems, Radiometer, Cepheid), based on public ownership records.
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 |
|---|---|---|---|
| GKZ | Counter, Differential Cell | 23 | 23 |
| JPK | Mixture, Hematology Quality Control | 5 | 5 |
| GKL | Counter, Cell, Automated (Particle Counter) | 3 | 3 |
| CIG | Diazo Colorimetry, Bilirubin | 2 | 2 |
| KHS | Enzymatic, Carbon-Dioxide | 2 | 2 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 | 1 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 1 | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 | 1 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 1 | 1 |
Plus 11 more product codes.
Review panels
- Hematology (33)
- Clinical Chemistry (17)
- Immunology (1)
Most recent Coulter Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K993356 | COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSES | GKZ | 2000-04-20 | 197 |
| K991070 | COULTER Z2 ANALYZER | GKL | 1999-05-11 | 41 |
| K990327 | RETICONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS | GKZ | 1999-04-26 | 83 |
| K990172 | TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS WITH CYTO-STAT TETRACHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 MONOCLA | GKZ | 1999-04-13 | 84 |
| K990352 | COULTER AC T DIFF 2 ANALYZER | GKZ | 1999-04-01 | 55 |
| K984216 | IMMUNO-TROL CONTROL CELLS | JPK | 1999-03-16 | 112 |
| K982167 | CYTO-STAT TRICHROME CD45-FITC/CD19-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1 | GKZ | 1998-11-09 | 143 |
| K982166 | CYTO-STAT TRICHROME CD45-FITC/CD56-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1 | GKZ | 1998-11-05 | 139 |
| K982172 | CYTO-STAT CD3-FITC/CD56-RDI MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT/COULTER CLONE MSIGGI-RD1/MSIGGI-FITC ISOTYPIC COL | GKZ | 1998-09-24 | 97 |
| K973634 | COULTER AC.T DIFF ANALYZER | GKZ | 1997-10-29 | 35 |
41 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Coulter Corp..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Coulter Electronics, Inc. (101 510(k)s)
- Coulter Immunology (16 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Coulter Corp.?
FDA lists 51 510(k) clearances under the applicant name “Coulter Corp.” (first 1989, latest 2000), across 21 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Coulter Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Coulter Corp. is 83 days.
Which FDA product codes appear under Coulter Corp.?
The most frequent FDA product codes under this applicant name are GKZ (Counter, Differential Cell, 23); JPK (Mixture, Hematology Quality Control, 5); GKL (Counter, Cell, Automated (Particle Counter), 3).
Next steps
- See all 51 Coulter Corp. clearances with predicates and recalls
- Run predicate analysis for product code GKZ, Coulter Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.