Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cogent Diagnotics , Ltd. — Predicate Candidate Screening
31 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
66 daysmedian FDA review time
149 days90th percentile
31clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K003054 | AUTOSTAT II ENA-6 PROFILE ELISA | Cogent Diagnotics , Ltd. | 2000-10-13 | 11 | 0 |
| K003057 | AUTOSTAT II ENA-4 PROFILE ELISA | Cogent Diagnotics , Ltd. | 2000-10-13 | 11 | 0 |
| K002215 | AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISA | Cogent Diagnotics , Ltd. | 2000-09-28 | 66 | 0 |
| K993557 | AUTOSTAT II RHEUMATOID FACTOR IGA ELISA | Cogent Diagnotics , Ltd. | 2000-03-03 | 135 | 0 |
| K994338 | AUTOSTAT II RHEUMATOID FACTOR IGM ELISA | Cogent Diagnotics , Ltd. | 2000-02-03 | 42 | 0 |
| K993085 | AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISA | Cogent Diagnotics , Ltd. | 2000-02-01 | 139 | 0 |
| K993304 | AUTOSTAT II RHEUMATOID FACTOR IGG ELISA | Cogent Diagnotics , Ltd. | 1999-12-06 | 63 | 0 |
| K992449 | AUTOSTAT II ANTI-CARDIOLIPIN IGM ELISA | Cogent Diagnotics , Ltd. | 1999-11-24 | 125 | 0 |
| K993087 | AUTOSTAT II ANTI-GLIADIN IGG ELISA | Cogent Diagnotics , Ltd. | 1999-11-12 | 58 | 0 |
| K993086 | AUTOSTAT II ANTI-GLIADIN IGA ELISA | Cogent Diagnotics , Ltd. | 1999-11-12 | 58 | 0 |
| K992440 | AUTOSTAT II ANTI-CARDIOLIPIN IGG ELISA | Cogent Diagnotics , Ltd. | 1999-09-21 | 61 | 0 |
| K991942 | AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISA | Cogent Diagnotics , Ltd. | 1999-08-24 | 76 | 0 |
| K991890 | AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA | Cogent Diagnotics , Ltd. | 1999-08-09 | 67 | 0 |
| K990624 | AUTOSTAT II ANTI-SM/RNP ELISA | Cogent Diagnotics , Ltd. | 1999-04-28 | 62 | 0 |
| K990798 | AUTOSTAT II ANTI-JO-1 ELISA | Cogent Diagnotics , Ltd. | 1999-04-28 | 49 | 0 |
| K990626 | AUTOSTAT II ANTI-SS-B/LA ELISA | Cogent Diagnotics , Ltd. | 1999-04-28 | 62 | 0 |
| K990797 | AUTOSTAT II ANTI-SCL-70 ELISA | Cogent Diagnotics , Ltd. | 1999-04-28 | 49 | 0 |
| K990627 | AUTOSTAT II ANTI-SS-A/RO ELISA | Cogent Diagnotics , Ltd. | 1999-04-28 | 62 | 0 |
| K990625 | AUTOSTAT II ANTI-SM ELISA | Cogent Diagnotics , Ltd. | 1999-04-28 | 62 | 0 |
| K990796 | AUTOSTAT II ANTI-PR 3 (C-ANCA)ELISA, HY*TEC ANTI-PR 3 (C-ANC | Cogent Diagnotics , Ltd. | 1999-04-28 | 49 | 0 |
| K983655 | AUTOSTAT II ANA SCREEN ELISA | Cogent Diagnotics , Ltd. | 1999-01-28 | 101 | 0 |
| K983921 | AUTOSTAT II ENA SCREEN ELISA | Cogent Diagnotics , Ltd. | 1998-12-28 | 54 | 0 |
| K952567 | AUTOSTATTMII ANTI-DSDNA | Cogent Diagnotics , Ltd. | 1997-03-04 | 638 | 0 |
| K943580 | AUTOSTAT II ANTI-TPO | Cogent Diagnotics , Ltd. | 1995-04-17 | 269 | 0 |
| K943625 | AUTOSTAT II ANTI-THYROGLOBULIN | Cogent Diagnotics , Ltd. | 1994-12-22 | 149 | 0 |
| K925783 | AUTOSTAT ANTI-DSDNA | Cogent Diagnotics , Ltd. | 1993-03-22 | 140 | 0 |
| K925784 | AUTOSTAT ANTITHYROGLOBIN | Cogent Diagnotics , Ltd. | 1993-01-21 | 79 | 0 |
| K925785 | AUTOSTAT ANTI-THYROID MICROSOMAL KIT | Cogent Diagnotics , Ltd. | 1993-01-21 | 79 | 0 |
| K923371 | AUTOSTAT ANTI-THYROID MICROSSOMAL | Cogent Diagnotics , Ltd. | 1992-09-22 | 75 | 0 |
| K923370 | AUTOSTAT ANTI-THYROGLOBULIN | Cogent Diagnotics , Ltd. | 1992-09-22 | 75 | 0 |
| K913342 | AUTOSTAT(TM) ANTI-DSNA | Cogent Diagnotics , Ltd. | 1992-05-01 | 280 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda