Clinetics Corp.: FDA filings under this applicant name
FDA lists 9 510(k) clearances under the applicant name “Clinetics Corp.” (first 1980, latest 1986), across 7 product codes in 2 review panels. Median 510(k) review time under this name: 42 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 |
|---|---|---|---|
| CEP | Radioimmunoassay, Luteinizing Hormone | 2 | 2 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 2 | 2 |
| CKG | Radioimmunoassay, Acth | 1 | 1 |
| DGC | Ige, Antigen, Antiserum, Control | 1 | 1 |
| DHX | System, Test, Carcinoembryonic Antigen | 1 | 1 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 1 | 1 |
| JZO | System, Test, Thyroid Autoantibody | 1 | 1 |
Review panels
- Clinical Chemistry (6)
- Immunology (3)
Most recent Clinetics Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K862180 | MODIFIED COTROPIN RADIOIMMUNOASSAY KIT | CEP | 1986-07-07 | 28 |
| K844066 | COTROPIN STIMULATANEOUS 57 CO-LH 125I I-FSH | CGJ | 1985-01-18 | 92 |
| K841580 | TSH RECEPTOR ANTIBODY KIT 125I TSH | JZO | 1984-10-22 | 188 |
| K833934 | ADRENOCORTICOTROPIC HORMONE TEST | CKG | 1984-04-04 | 142 |
| K830357 | RADIOIMMUNOASSAY IMMUNOGLOBULINS D.E | DGC | 1983-03-17 | 42 |
| K823380 | 125-I LH RADIOIMMUNOASSAY KIT | CEP | 1982-12-22 | 40 |
| K823379 | 125-I FSH RADIOIMMUNOASSAY KIT | CGJ | 1982-12-22 | 40 |
| K822152 | HCG BETA RIA KIT | JHI | 1982-09-02 | 41 |
| K801306 | CLINETICS PCA COLUMN | DHX | 1980-09-26 | 115 |
Recalls
openFDA lists no recalls under a recalling firm named Clinetics Corp..
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 Clinetics Corp.?
FDA lists 9 510(k) clearances under the applicant name “Clinetics Corp.” (first 1980, latest 1986), across 7 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 Clinetics Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Clinetics Corp. is 42 days.
Which FDA product codes appear under Clinetics Corp.?
The most frequent FDA product codes under this applicant name are CEP (Radioimmunoassay, Luteinizing Hormone, 2); CGJ (Radioimmunoassay, Follicle-Stimulating Hormone, 2); CKG (Radioimmunoassay, Acth, 1).
Next steps
- See all 9 Clinetics Corp. clearances with predicates and recalls
- Run predicate analysis for product code CEP, Clinetics Corp.'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.