Coulter Immunology: FDA filings under this applicant name
FDA lists 16 510(k) clearances under the applicant name “Coulter Immunology” (first 1988, latest 1993), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 156 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 | 14 | 14 |
| DEW | Igg, Antigen, Antiserum, Control | 1 | 1 |
| GGK | Products, Red-Cell Lysing Products | 1 | 1 |
Review panels
- Hematology (15)
- Immunology (1)
Most recent Coulter Immunology 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K922745 | CYTO-STAT/COULTER CLONE CD3(IGG1)-FITC/T4-RD1 | GKZ | 1993-02-05 | 242 |
| K922744 | CYTO-STAT/COULTER CLONE CD 3(IGG1)-FITC/T8-RD1 | GKZ | 1993-02-05 | 242 |
| K910473 | CYTO-STAT(R)/COULTER CLONE(R) T11-RD1/B4-FITC | GKZ | 1991-10-31 | 269 |
| K911793 | COULTERCLONE | GKZ | 1991-07-09 | 78 |
| K893853 | COULTER CLONE T8 MONOCLONAL ANTIBODY | GKZ | 1990-03-02 | 281 |
| K893852 | COULTER CLONE T4 MONOCLONAL ANTIBODY | GKZ | 1990-03-02 | 281 |
| K894179 | COULTER CLONE(R) MY4 MONOCLONAL ANTIBODY | GKZ | 1990-02-12 | 241 |
| K895917 | CYTO-STAT/COULTER CLONE T4-RD1/T8-FITC MONO ANTI | GKZ | 1989-12-29 | 80 |
| K884605 | COULTER CLONE MO2 | GKZ | 1989-08-15 | 285 |
| K893419 | COULTER CLONE GAM-FITC POLY ANTI (IGG & IGM) | DEW | 1989-08-03 | 93 |
6 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Coulter Immunology.
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 Corp. (51 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Coulter Immunology?
FDA lists 16 510(k) clearances under the applicant name “Coulter Immunology” (first 1988, latest 1993), across 3 product codes in 2 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 Immunology?
The median time from FDA receipt to decision across 510(k)s cleared under the name Coulter Immunology is 156 days.
Which FDA product codes appear under Coulter Immunology?
The most frequent FDA product codes under this applicant name are GKZ (Counter, Differential Cell, 14); DEW (Igg, Antigen, Antiserum, Control, 1); GGK (Products, Red-Cell Lysing Products, 1).
Next steps
- See all 16 Coulter Immunology clearances with predicates and recalls
- Run predicate analysis for product code GKZ, Coulter Immunology'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.