Serono-Baker Diagnostics, Inc.: FDA clearances and approvals
Serono-Baker Diagnostics, Inc. has 23 FDA 510(k) clearances (first 1988, latest 1992), across 16 product codes in 3 review panels. Median 510(k) review time: 69 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 |
|---|---|---|---|
| CHP | Radioimmunoassay, Estradiol | 4 | 4 |
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 2 | 2 |
| CGR | Radioimmunoassay, Cortisol | 2 | 2 |
| DBF | Ferritin, Antigen, Antiserum, Control | 2 | 2 |
| JLS | Radioimmunoassay, Progesterone | 2 | 2 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 | 1 |
| CEC | Radioimmunoassay, Free Thyroxine | 1 | 1 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 1 | 1 |
| CFT | Radioimmunoassay, Prolactin (Lactogen) | 1 | 1 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 | 1 |
Plus 6 more product codes.
Review panels
- Clinical Chemistry (20)
- Immunology (2)
- Clinical Toxicology (1)
Most recent Serono-Baker Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K924257 | TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAY | CDZ | 1992-11-30 | 98 |
| K915164 | SRI TESTOSTERONE ENZYME IMMUNOASSAY | CDZ | 1992-03-02 | 109 |
| K914886 | SRI(TM) CORTISOL ENZYME IMMUNOASSAY(MAG SOL PHASE) | CGR | 1992-03-02 | 124 |
| K915602 | SRI DIGOXIN ENZYME IMMUNOASSAY | KXT | 1992-01-17 | 35 |
| K912937 | SR1 FREE T4 ENZYME IMMUNOASSAY | CEC | 1991-11-19 | 137 |
| K914462 | SRI PROGESTERONE ENZYME IMMUNOASSAY(MAG SOLD PHAS) | JLS | 1991-10-23 | 16 |
| K911912 | SR1 T3 UPTAKE ENZYME IMMUNOASSAY(MAG SOLID-PHASE) | KHQ | 1991-09-18 | 141 |
| K911217 | SR1 T4 ENZYME IMMUNOASSAY (MAGNETIC SOLID-PHASE) | KLI | 1991-08-16 | 150 |
| K912318 | ESTRADIOL SEROZYME ENZYME IMMUNO (MAG SOLID-PHASE) | CHP | 1991-07-25 | 62 |
| K911396 | SR1 ESTRADIOL ENZYME IMMUNOASSAY | CHP | 1991-05-28 | 60 |
13 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Serono-Baker 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 Serono-Baker Diagnostics, Inc. have?
Serono-Baker Diagnostics, Inc. has 23 FDA 510(k) clearances (first 1988, latest 1992), across 16 product codes in 3 review panels.
How long does FDA take to clear Serono-Baker Diagnostics, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Serono-Baker Diagnostics, Inc.'s cleared 510(k)s is 69 days.
What devices does Serono-Baker Diagnostics, Inc. make?
Its most frequent FDA product codes are CHP (Radioimmunoassay, Estradiol, 4); CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone, 2); CGR (Radioimmunoassay, Cortisol, 2).
Has Serono-Baker Diagnostics, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Serono-Baker Diagnostics, Inc. Related entities may recall under other names.
Next steps
- See all 23 Serono-Baker Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CHP, Serono-Baker 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.