Nuclear Medical Laboratories, Inc.: FDA filings under this applicant name
FDA lists 24 510(k) clearances under the applicant name “Nuclear Medical Laboratories, Inc.” (first 1976, latest 1985), across 15 product codes in 2 review panels. Median 510(k) review time under this name: 32 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 |
|---|---|---|---|
| JHI | Visual, Pregnancy Hcg, Prescription Use | 5 | 5 |
| CGR | Radioimmunoassay, Cortisol | 3 | 3 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 3 | 3 |
| JJJ | Counter (Beta, Gamma) For Clinical Use | 2 | 2 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 | 1 |
| CDX | Radioimmunoassay, Total Thyroxine | 1 | 1 |
| CFT | Radioimmunoassay, Prolactin (Lactogen) | 1 | 1 |
| DMP | Digoxin Control Serum, Ria | 1 | 1 |
| DPB | Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Charcoal Sep. | 1 | 1 |
| JFH | Acid Phosphatase (Prostatic), Tartrate Inhibited | 1 | 1 |
Plus 5 more product codes.
Review panels
Most recent Nuclear Medical Laboratories, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K852438 | NML TSH IRMA | JLW | 1985-07-12 | 32 |
| K844583 | TSH-STAT | JLW | 1985-03-05 | 102 |
| K840466 | NML CORTISOL RIA | CGR | 1984-03-30 | 56 |
| K840589 | TRI-TUBE RIA | KHQ | 1984-03-09 | 29 |
| K832892 | MODIFIED CHORIO-SHURE | JHI | 1983-10-28 | 63 |
| K832002 | NML-5010/5020 MULTI-DETECTOR SYSTEM | JJJ | 1983-08-08 | 47 |
| K823679 | NML 6000 CT | JQP | 1983-01-07 | 31 |
| K823053 | NML-TETRA-TUBE RIA | CDX | 1982-11-10 | 23 |
| K822298 | DIAGNOSTIC RADIOIMMUNOASSAY FOR QUANTI | JFH | 1982-09-02 | 30 |
| K820523 | CHORIO-QUANT | JHI | 1982-03-15 | 17 |
14 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Nuclear Medical Laboratories, Inc..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Nuclear Diagnostics, Inc. (23 510(k)s)
- Nuclear Data, Inc. (7 510(k)s)
- Nuclear Medical Systems, Inc. (5 510(k)s)
- Nuclear Ent. , Ltd. (3 510(k)s)
- Nuclear Cardiology Systems, Inc. (2 510(k)s)
- Nuclear Data Systems (2 510(k)s)
- Nuclear Assoc., Div. Inovision LP (1 510(k)s)
- Nuclear Associates (1 510(k)s)
- Nuclear Concepts, Inc. (1 510(k)s)
- Nuclear Diagnostics AB (1 510(k)s)
- Nuclear Medicine, Inc. (1 510(k)s)
- Nuclear Pacific, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Nuclear Medical Laboratories, Inc.?
FDA lists 24 510(k) clearances under the applicant name “Nuclear Medical Laboratories, Inc.” (first 1976, latest 1985), across 15 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 Nuclear Medical Laboratories, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nuclear Medical Laboratories, Inc. is 32 days.
Which FDA product codes appear under Nuclear Medical Laboratories, Inc.?
The most frequent FDA product codes under this applicant name are JHI (Visual, Pregnancy Hcg, Prescription Use, 5); CGR (Radioimmunoassay, Cortisol, 3); JLW (Radioimmunoassay, Thyroid-Stimulating Hormone, 3).
Next steps
- See all 24 Nuclear Medical Laboratories, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JHI, Nuclear Medical Laboratories, Inc.'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.