Enzo Biochem, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Enzo Biochem, Inc.” (first 1987, latest 1988), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 90 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 |
|---|---|---|---|
| GQN | Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2 | 2 | 2 |
| GQH | Antigen, Cf (Including Cf Control), Cytomegalovirus | 1 | 1 |
| GQM | Antisera, Neutralization, Herpesvirus Hominis | 1 | 1 |
| KHE | Reagent, Occult Blood | 1 | 1 |
Review panels
- Microbiology (4)
- Hematology (1)
Most recent Enzo Biochem, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K880604 | COLORGENE HSV DNA HYBRIDIZATION TEST | GQN | 1988-08-03 | 173 |
| K881907 | HEMAGEL(TM) TEST FOR FECAL OCCULT BLOOD | KHE | 1988-07-08 | 63 |
| K875367 | COLORGENE FLUORESCENT DNA HYBRIDIZATION TEST / CMV | GQM | 1988-03-28 | 88 |
| K872576 | COLORGENE DNA HYBRIDIZATION TEST CMV CONFIRMATION | GQH | 1987-12-04 | 157 |
| K870733 | COLORGENE DNA HYBRIDIZATION TEST FOR HSV CONFIRMA. | GQN | 1987-05-26 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Enzo Biochem, 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 Enzo Biochem, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Enzo Biochem, Inc.” (first 1987, latest 1988), across 4 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 Enzo Biochem, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Enzo Biochem, Inc. is 90 days.
Which FDA product codes appear under Enzo Biochem, Inc.?
The most frequent FDA product codes under this applicant name are GQN (Antigen, Cf (Including Cf Control), Herpesvirus Hominis 1,2, 2); GQH (Antigen, Cf (Including Cf Control), Cytomegalovirus, 1); GQM (Antisera, Neutralization, Herpesvirus Hominis, 1).
Next steps
- See all 5 Enzo Biochem, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GQN, Enzo Biochem, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.