Cambridge Nuclear Corp.: FDA clearances and approvals
Cambridge Nuclear Corp. has 5 FDA 510(k) clearances (first 1979, latest 1981), across 4 product codes in 1 review panel. Median 510(k) review time: 55 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 |
|---|---|---|---|
| CGI | Radioimmunoassay, Estriol | 2 | 2 |
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | 1 | 1 |
| JLS | Radioimmunoassay, Progesterone | 1 | 1 |
Plus 1 more product codes.
Review panels
Most recent Cambridge Nuclear Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K811380 | ESTRIOL KIT | CGI | 1981-06-09 | 25 |
| K810804 | PROGESTERONE KIT | JLS | 1981-04-01 | 8 |
| K790362 | I BRADYKININ & ANTI-BRADYKININ ANTISERUM | — | 1979-04-23 | 60 |
| K790008 | I ESTRIOL | CGI | 1979-02-26 | 55 |
| K790007 | I TESTOTERONE | CDZ | 1979-02-26 | 55 |
Recalls
openFDA lists no recalls under a recalling firm named Cambridge Nuclear Corp..
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 Cambridge Nuclear Corp. have?
Cambridge Nuclear Corp. has 5 FDA 510(k) clearances (first 1979, latest 1981), across 4 product codes in 1 review panel.
How long does FDA take to clear Cambridge Nuclear Corp.'s 510(k)s?
The median time from FDA receipt to decision across Cambridge Nuclear Corp.'s cleared 510(k)s is 55 days.
What devices does Cambridge Nuclear Corp. make?
Its most frequent FDA product codes are CGI (Radioimmunoassay, Estriol, 2); CDZ (Radioimmunoassay, Testosterones And Dihydrotestosterone, 1); JLS (Radioimmunoassay, Progesterone, 1).
Has Cambridge Nuclear Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Cambridge Nuclear Corp. Related entities may recall under other names.
Next steps
- See all 5 Cambridge Nuclear Corp. clearances with predicates and recalls
- Run predicate analysis for product code CGI, Cambridge Nuclear Corp.'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.