Clinical Diagnostics, Inc.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Clinical Diagnostics, Inc.” (first 1977, latest 1998), across 6 product codes in 2 review panels. Median 510(k) review time under this name: 130 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 |
|---|---|---|---|
| CGA | Glucose Oxidase, Glucose | 3 | 3 |
| CDX | Radioimmunoassay, Total Thyroxine | 1 | 1 |
| CEM | Electrode, Ion Specific, Potassium | 1 | 1 |
| CGR | Radioimmunoassay, Cortisol | 1 | 1 |
| JJG | Analyzer, Chemistry, Centrifugal, For Clinical Use | 1 | 1 |
| LQD | Recorder, Attention Task Performance | 1 | 1 |
Review panels
- Clinical Chemistry (7)
- Neurology (1)
Most recent Clinical Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K971653 | GLUCOCHEK POCKETLAB II BLOOD GLUCOSE SYSTEM | CGA | 1998-01-02 | 241 |
| K951457 | GLUCOCHEK POCKETLAB | CGA | 1996-02-22 | 330 |
| K940215 | GLUCOCHEK | CGA | 1995-01-17 | 368 |
| K854903 | GORDON DIAGNOSTIC SYSTEM MODEL I | LQD | 1986-06-02 | 175 |
| K771813 | CENTRIFICHEM SYS 400 ANALYZER | JJG | 1977-10-25 | 28 |
| K771118 | CENTRIA SEPARATION COLUMNS TYPE A | CEM | 1977-07-11 | 20 |
| K771117 | CENTRIA CORTISOL RIA | CGR | 1977-06-23 | 2 |
| K761272 | CENTRIA T4 RIA | CDX | 1977-03-16 | 86 |
Recalls
openFDA lists no recalls under a recalling firm named Clinical Diagnostics, 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 Assays, Inc. (27 510(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 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 Diagnostics, Inc.?
FDA lists 8 510(k) clearances under the applicant name “Clinical Diagnostics, Inc.” (first 1977, latest 1998), across 6 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 Clinical Diagnostics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Clinical Diagnostics, Inc. is 130 days.
Which FDA product codes appear under Clinical Diagnostics, Inc.?
The most frequent FDA product codes under this applicant name are CGA (Glucose Oxidase, Glucose, 3); CDX (Radioimmunoassay, Total Thyroxine, 1); CEM (Electrode, Ion Specific, Potassium, 1).
Next steps
- See all 8 Clinical Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CGA, Clinical Diagnostics, 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.