Cogent Diagnotics , Ltd.: FDA filings under this applicant name
FDA lists 31 510(k) clearances under the applicant name “Cogent Diagnotics , Ltd.” (first 1992, latest 2000), across 16 product codes in 2 review panels. Median 510(k) review time under this name: 66 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 |
|---|---|---|---|
| LLL | Extractable Antinuclear Antibody, Antigen And Control | 7 | 7 |
| DHR | System, Test, Rheumatoid Factor | 3 | 3 |
| JNL | Immunochemical, Thyroglobulin Autoantibody | 3 | 3 |
| MID | System, Test, Anticardiolipin Immunological | 3 | 3 |
| JZO | System, Test, Thyroid Autoantibody | 2 | 2 |
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 2 | 2 |
| MST | Antibodies, Gliadin | 2 | 2 |
| DDC | Thyroglobulin, Antigen, Antiserum, Control | 1 | 1 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 | 1 |
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 1 | 1 |
Plus 6 more product codes.
Review panels
- Immunology (30)
- Clinical Chemistry (1)
Most recent Cogent Diagnotics , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K003057 | AUTOSTAT II ENA-4 PROFILE ELISA | LLL | 2000-10-13 | 11 |
| K003054 | AUTOSTAT II ENA-6 PROFILE ELISA | LLL | 2000-10-13 | 11 |
| K002215 | AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISA | MOB | 2000-09-28 | 66 |
| K993557 | AUTOSTAT II RHEUMATOID FACTOR IGA ELISA | DHR | 2000-03-03 | 135 |
| K994338 | AUTOSTAT II RHEUMATOID FACTOR IGM ELISA | DHR | 2000-02-03 | 42 |
| K993085 | AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISA | MID | 2000-02-01 | 139 |
| K993304 | AUTOSTAT II RHEUMATOID FACTOR IGG ELISA | DHR | 1999-12-06 | 63 |
| K992449 | AUTOSTAT II ANTI-CARDIOLIPIN IGM ELISA | MID | 1999-11-24 | 125 |
| K993087 | AUTOSTAT II ANTI-GLIADIN IGG ELISA | MST | 1999-11-12 | 58 |
| K993086 | AUTOSTAT II ANTI-GLIADIN IGA ELISA | MST | 1999-11-12 | 58 |
21 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Cogent Diagnotics , Ltd..
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.
- Cogent Light Technologies, Inc. (5 510(k)s)
- Cogent Spine, LLC (3 510(k)s)
- Cogent (1 510(k)s)
- Cogent Therapeutics, LLC (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cogent Diagnotics , Ltd.?
FDA lists 31 510(k) clearances under the applicant name “Cogent Diagnotics , Ltd.” (first 1992, latest 2000), across 16 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 Cogent Diagnotics , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cogent Diagnotics , Ltd. is 66 days.
Which FDA product codes appear under Cogent Diagnotics , Ltd.?
The most frequent FDA product codes under this applicant name are LLL (Extractable Antinuclear Antibody, Antigen And Control, 7); DHR (System, Test, Rheumatoid Factor, 3); JNL (Immunochemical, Thyroglobulin Autoantibody, 3).
Next steps
- See all 31 Cogent Diagnotics , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LLL, Cogent Diagnotics , Ltd.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.