Genus Diagnostics: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Genus Diagnostics” (first 1985, latest 1986), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 18 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 |
|---|---|---|---|
| KIR | Cells, Animal And Human, Cultured | 8 | 8 |
| GQN | Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2 | 1 | 1 |
Review panels
- Pathology (8)
- Microbiology (1)
Most recent Genus Diagnostics 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K854974 | HSV IDR | GQN | 1986-03-07 | 85 |
| K852206 | HEP-2 GENCELLS | KIR | 1985-06-04 | 14 |
| K852205 | RMK GENCELLS CULTURE SYSTEM | KIR | 1985-06-04 | 14 |
| K852204 | MCCOY GENCELLS | KIR | 1985-06-04 | 14 |
| K851928 | HEK GENCELLS | KIR | 1985-05-20 | 18 |
| K851927 | VERO GENCELLS | KIR | 1985-05-20 | 18 |
| K851563 | RK GENCELLS | KIR | 1985-05-10 | 24 |
| K851562 | MRC-5 GENCELLS | KIR | 1985-05-10 | 24 |
| K851561 | WI-38 GENCELLS | KIR | 1985-05-10 | 24 |
Recalls
openFDA lists no recalls under a recalling firm named Genus Diagnostics.
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.
- Genus Medical, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Genus Diagnostics?
FDA lists 9 510(k) clearances under the applicant name “Genus Diagnostics” (first 1985, latest 1986), 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 Genus Diagnostics?
The median time from FDA receipt to decision across 510(k)s cleared under the name Genus Diagnostics is 18 days.
Which FDA product codes appear under Genus Diagnostics?
The most frequent FDA product codes under this applicant name are KIR (Cells, Animal And Human, Cultured, 8); GQN (Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2, 1).
Next steps
- See all 9 Genus Diagnostics clearances with predicates and recalls
- Run predicate analysis for product code KIR, Genus Diagnostics'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.