New England Nuclear: FDA filings under this applicant name
FDA lists 18 510(k) clearances under the applicant name “New England Nuclear” (first 1976, latest 1984), across 14 product codes in 2 review panels. Median 510(k) review time under this name: 30 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| CDD | Radioassay, Vitamin B12 | 2 | 2 |
| CGI | Radioimmunoassay, Estriol | 2 | 2 |
| CGR | Radioimmunoassay, Cortisol | 2 | 2 |
| DJB | Radioimmunoassay, Gentamicin (125-I), Second Antibody Sep. | 2 | 2 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 1 | 1 |
| CFT | Radioimmunoassay, Prolactin (Lactogen) | 1 | 1 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 | 1 |
| CHO | Radioimmunoassay, Cyclic Amp | 1 | 1 |
| DID | Bacillus Subtilis Microbiology Assay, Tobramycin | 1 | 1 |
| DNL | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second Antibody Sep. | 1 | 1 |
Plus 4 more product codes.
Review panels
Most recent New England Nuclear 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K841478 | RIANEN CYCLIC-AMP RADIOIMMUNOASSAY | CHO | 1984-06-14 | 66 |
| K840301 | RIANEN ESTRIOL RADIOIMMUNOASSAY KIT | CGI | 1984-03-30 | 66 |
| K834038 | RIANEN FOLLICLE STIMULATING HORMONE | CGJ | 1984-01-30 | 68 |
| K833376 | RIANEN LUTEINIZING HORMONE RIA KIT | CEP | 1983-12-20 | 83 |
| K831345 | RIANEN PROLACTIN 125I KIT | CFT | 1983-06-08 | 44 |
| K801245 | ATOMLIGHT (LIQUID SCINTILLATION SOLUTION | JJJ | 1980-06-20 | 24 |
| K792175 | RIANEN, VITAMIN B12 ASSAY SYSTEM | CDD | 1979-11-13 | 15 |
| K790817 | RIA KIT, QUANTITATION OF PROSTATIC ACID | JFH | 1979-05-07 | 10 |
| K782110 | RIA KIT, RIANEN CORTISOL | CGR | 1979-01-26 | 38 |
| K781888 | ASSAY SYSTEM, FERRITIN I KIT | JMG | 1979-01-10 | 64 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named New England Nuclear.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under New England Nuclear?
FDA lists 18 510(k) clearances under the applicant name “New England Nuclear” (first 1976, latest 1984), across 14 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by New England Nuclear?
The median time from FDA receipt to decision across 510(k)s cleared under the name New England Nuclear is 30 days.
Which FDA product codes appear under New England Nuclear?
The most frequent FDA product codes under this applicant name are CDD (Radioassay, Vitamin B12, 2); CGI (Radioimmunoassay, Estriol, 2); CGR (Radioimmunoassay, Cortisol, 2).
Next steps
- See all 18 New England Nuclear clearances with predicates and recalls
- Run predicate analysis for product code CDD, New England Nuclear's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.