Seragen Diagnostics, Inc.: FDA clearances and approvals
Seragen Diagnostics, Inc. has 20 FDA 510(k) clearances (first 1982, latest 1987), across 18 product codes in 4 review panels. Median 510(k) review time: 70 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 |
|---|---|---|---|
| GKL | Counter, Cell, Automated (Particle Counter) | 2 | 2 |
| JJT | Enzyme Controls (Assayed And Unassayed) | 2 | 2 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 | 1 |
| CEX | Chromatographic Separation, Lactate Dehydrogenase Isoenzymes | 1 | 1 |
| CFM | Bathophenanthroline, Colorimetry, Iron (Non-Heme) | 1 | 1 |
| CGA | Glucose Oxidase, Glucose | 1 | 1 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 1 | 1 |
| CKG | Radioimmunoassay, Acth | 1 | 1 |
| DHR | System, Test, Rheumatoid Factor | 1 | 1 |
| GIF | Diluent, Blood Cell | 1 | 1 |
Plus 8 more product codes.
Review panels
- Clinical Chemistry (11)
- Hematology (4)
- Immunology (3)
- Microbiology (2)
Most recent Seragen Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K872148 | VIVID CHLAMYDIA(TM) | LJC | 1987-08-19 | 76 |
| K851663 | QUICK-COUNT HEMATOLOGY CONTROLS | JPK | 1985-07-23 | 91 |
| K852260 | QUICK-CHEM CALIBRATION SET | JIW | 1985-07-22 | 59 |
| K851520 | CK/LD ISOENZYMES CONTROLS(HUMAN) | JJT | 1985-06-25 | 71 |
| K851521 | LD-1(IMMUNO) SEPARATION SET | CEX | 1985-05-10 | 25 |
| K850209 | QUICK-LYTE | JGS | 1985-02-27 | 40 |
| K844743 | SERATEST ENA(RNP/SM) DETERMINATION | LLL | 1985-02-04 | 61 |
| K842563 | SERATEST DNA DETERMINATION | LKJ | 1984-10-25 | 115 |
| K841504 | QUICK-COUNT PLUS 2 | GKL | 1984-06-11 | 62 |
| K840793 | CK/MB IMMUNO-ISOENZYME CONTROL SERUM | JJT | 1984-04-13 | 50 |
10 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Seragen Diagnostics, 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 Seragen Diagnostics, Inc. have?
Seragen Diagnostics, Inc. has 20 FDA 510(k) clearances (first 1982, latest 1987), across 18 product codes in 4 review panels.
How long does FDA take to clear Seragen Diagnostics, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Seragen Diagnostics, Inc.'s cleared 510(k)s is 70 days.
What devices does Seragen Diagnostics, Inc. make?
Its most frequent FDA product codes are GKL (Counter, Cell, Automated (Particle Counter), 2); JJT (Enzyme Controls (Assayed And Unassayed), 2); CDQ (Urease And Glutamic Dehydrogenase, Urea Nitrogen, 1).
Has Seragen Diagnostics, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Seragen Diagnostics, Inc. Related entities may recall under other names.
Next steps
- See all 20 Seragen Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GKL, Seragen Diagnostics, 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.