Clinical Assays, Inc.: FDA filings under this applicant name
FDA lists 27 510(k) clearances under the applicant name “Clinical Assays, Inc.” (first 1977, latest 1983), across 22 product codes in 4 review panels. Median 510(k) review time under this name: 45 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 |
|---|---|---|---|
| CDX | Radioimmunoassay, Total Thyroxine | 3 | 3 |
| CGN | Acid, Folic, Radioimmunoassay | 3 | 3 |
| CDD | Radioassay, Vitamin B12 | 2 | 2 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 | 1 |
| CEE | Radioimmunoassay, Thyroxine-Binding Globulin | 1 | 1 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 1 | 1 |
| CFP | Radioimmunoassay, Immunoreactive Insulin | 1 | 1 |
| CGC | Radioimmunoassay, Gastrin | 1 | 1 |
| CGI | Radioimmunoassay, Estriol | 1 | 1 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 | 1 |
Plus 12 more product codes.
Review panels
- Clinical Chemistry (19)
- Clinical Toxicology (4)
- Immunology (2)
- Microbiology (1)
Most recent Clinical Assays, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K832712 | FOLATE RADIOASSAY KIT CA-1562-125 | CGN | 1983-10-04 | 53 |
| K832711 | VITAMIN B12 FOLATE CA-1515-125 | CDD | 1983-10-04 | 53 |
| K832710 | VITAMIN B12 RADIOASSAY KIT CA-1534 | CDD | 1983-10-04 | 53 |
| K823476 | GAMMADAB LH RADIO-KIT #CA-1508 | CEP | 1982-12-28 | 36 |
| K823313 | IN VITRO GAMMACOAT B-HCG RADIO. TEST | JHI | 1982-12-22 | 47 |
| K821611 | GAMMADAB [125] FSH RADIOIMMUNAY KIT | CGJ | 1982-06-24 | 22 |
| K821092 | GAMMADAB[125]EGE RADIOIMMUNOASSAY IT | DGC | 1982-06-22 | 64 |
| K812227 | GAMMACOAT (125) INSULIN RADIOIMMUNOASSAY | CFP | 1981-09-24 | 45 |
| K810722 | GASTRIN RADIOIMMUNOASSAY TEST | CGC | 1981-05-27 | 71 |
| K810967 | IN-VITRO TBG RADIOIMMUNOASSAY TEST | CEE | 1981-04-23 | 15 |
17 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Clinical Assays, 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.
- Clinical Data, Inc. (37 510(k)s)
- Clinical Sciences, Inc. (30 510(k)s)
- Clinical Controls, Inc. (18 510(k)s)
- Clinical Innovations, LLC (18 510(k)s)
- Clinical Resources, Inc. (14 510(k)s)
- Clinical Technology Corp. (12 510(k)s)
- Clinical Connections, Inc. (10 510(k)s)
- Clinical Diagnostics, Inc. (8 510(k)s)
- Clinical Convenience Products, Inc. (6 510(k)s)
- Clinical Laserthermia Systems, AB (6 510(k)s)
- Clinical Neuro Systems, LLC (5 510(k)s)
- Clinical Bioresearch (4 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Clinical Assays, Inc.?
FDA lists 27 510(k) clearances under the applicant name “Clinical Assays, Inc.” (first 1977, latest 1983), across 22 product codes in 4 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 Clinical Assays, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Clinical Assays, Inc. is 45 days.
Which FDA product codes appear under Clinical Assays, Inc.?
The most frequent FDA product codes under this applicant name are CDX (Radioimmunoassay, Total Thyroxine, 3); CGN (Acid, Folic, Radioimmunoassay, 3); CDD (Radioassay, Vitamin B12, 2).
Next steps
- See all 27 Clinical Assays, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CDX, Clinical Assays, 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.