Serex, Inc.: FDA clearances and approvals
Serex, Inc. has 5 FDA 510(k) clearances (first 1989, latest 1992), across 3 product codes in 2 review panels. Median 510(k) review time: 48 days.
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 |
|---|---|---|---|
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 2 | 2 |
| JZG | System, Test, Beta-2-Microglobulin Immunological | 2 | 2 |
| JXO | Enzyme Immunoassay, Cocaine | 1 | 1 |
Review panels
- Clinical Toxicology (3)
- Immunology (2)
Most recent Serex, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K923314 | AUTOMATES COMA PLUS COCAINE METABOLITE ASSAY | JXO | 1992-08-24 | 48 |
| K921834 | AUTOMATES COMA COCAINE METABOLITE ASSAY | DIO | 1992-06-15 | 60 |
| K901333 | BETA-2 MICROGLOBULIN EIA | JZG | 1990-04-02 | 13 |
| K895043 | COMA COCAINE METABOLITE ASSAY (EIA) | DIO | 1989-11-08 | 91 |
| K890694 | BETA-2 MICROGLOBULIN EIA | JZG | 1989-03-16 | 34 |
Recalls
openFDA lists no recalls under a recalling firm named Serex, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Serex, Inc. have?
Serex, Inc. has 5 FDA 510(k) clearances (first 1989, latest 1992), across 3 product codes in 2 review panels.
How long does FDA take to clear Serex, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Serex, Inc.'s cleared 510(k)s is 48 days.
What devices does Serex, Inc. make?
Its most frequent FDA product codes are DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites, 2); JZG (System, Test, Beta-2-Microglobulin Immunological, 2); JXO (Enzyme Immunoassay, Cocaine, 1).
Has Serex, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Serex, Inc. Related entities may recall under other names.
Next steps
- See all 5 Serex, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DIO, Serex, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.