Gen Trak, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Gen Trak, Inc.” (first 1992, latest 1992), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 235 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 | 4 | 4 |
| LIZ | Assay, T Lymphocyte Surface Marker | 1 | 1 |
Review panels
- Hematology (4)
- Immunology (1)
Most recent Gen Trak, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K922085 | MONOCLONAL ANTIBODY IGG2A ISOTYPE CONT. FLOW CYTOM | GKZ | 1992-07-28 | 85 |
| K922084 | MONOMCLONAL ANTIBODY IGG1 ISOTYPE CONT. FLOW CYTOM | GKZ | 1992-07-28 | 85 |
| K914848 | CD4 MONOCLONAL ANTIBODIES | GKZ | 1992-06-19 | 235 |
| K914847 | CD8 MONOCLONAL ANTIBODIES | LIZ | 1992-06-19 | 235 |
| K914846 | CD2 MONOCLONAL ANTIBODIES | GKZ | 1992-06-19 | 235 |
Recalls
openFDA lists no recalls under a recalling firm named Gen Trak, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Gen Trak, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Gen Trak, Inc.” (first 1992, latest 1992), across 2 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 Gen Trak, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Gen Trak, Inc. is 235 days.
Which FDA product codes appear under Gen Trak, Inc.?
The most frequent FDA product codes under this applicant name are GKZ (Counter, Differential Cell, 4); LIZ (Assay, T Lymphocyte Surface Marker, 1).
Next steps
- See all 5 Gen Trak, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GKZ, Gen Trak, Inc.'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.