Squibb & Sons, Inc.: FDA clearances and approvals
Squibb & Sons, Inc. has 5 FDA 510(k) clearances (first 1976, latest 1982), across 5 product codes in 2 review panels. Median 510(k) review time: 18 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 |
|---|---|---|---|
| CDX | Radioimmunoassay, Total Thyroxine | 1 | 1 |
| CGI | Radioimmunoassay, Estriol | 1 | 1 |
| CIB | Radioimmunoassay, Angiotensin I And Renin | 1 | 1 |
| EXB | Collector, Ostomy | 1 | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 | 1 |
Review panels
Most recent Squibb & Sons, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K821174 | TSH-SQUIBB RADIOIMMUNOASSAY KIT | JLW | 1982-05-14 | 18 |
| K801424 | ESTRIOL RIA KIT FOR USE WITH GAMMAFLO | CGI | 1980-07-21 | 34 |
| K800750 | STOMAHESIVE STERILE WAFER | EXB | 1980-05-08 | 34 |
| K770726 | RIA KIT, T4 CLASP | CDX | 1977-04-28 | 9 |
| K761267 | ANGIOTENSIN I IMMUTOPE KIT | CIB | 1976-12-30 | 14 |
Recalls
openFDA lists no recalls under a recalling firm named Squibb & Sons, 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 Squibb & Sons, Inc. have?
Squibb & Sons, Inc. has 5 FDA 510(k) clearances (first 1976, latest 1982), across 5 product codes in 2 review panels.
How long does FDA take to clear Squibb & Sons, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Squibb & Sons, Inc.'s cleared 510(k)s is 18 days.
What devices does Squibb & Sons, Inc. make?
Its most frequent FDA product codes are CDX (Radioimmunoassay, Total Thyroxine, 1); CGI (Radioimmunoassay, Estriol, 1); CIB (Radioimmunoassay, Angiotensin I And Renin, 1).
Has Squibb & Sons, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Squibb & Sons, Inc. Related entities may recall under other names.
Next steps
- See all 5 Squibb & Sons, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CDX, Squibb & Sons, 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.