Company ยท GB
Cogent Diagnotics , Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 1992 to 2000. Name variants (Inc, Corp, punctuation) are merged.
31510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LLL | Extractable Antinuclear Antibody, Antigen And Control | 7 |
| DHR | System, Test, Rheumatoid Factor | 3 |
| JNL | Immunochemical, Thyroglobulin Autoantibody | 3 |
| MID | System, Test, Anticardiolipin Immunological | 3 |
| JZO | System, Test, Thyroid Autoantibody | 2 |
| MOB | Test System, Antineutrophil Cytoplasmic Antibodies (Anca) | 2 |
| MST | Antibodies, Gliadin | 2 |
| DDC | Thyroglobulin, Antigen, Antiserum, Control | 1 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 |
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 1 |
| LKJ | Antinuclear Antibody, Antigen, Control | 1 |
| LKO | Anti-Rnp Antibody, Antigen And Control | 1 |
| LKP | Anti-Sm Antibody, Antigen And Control | 1 |
| LRM | Anti-Dna Antibody (Enzyme-Labeled), Antigen, Control | 1 |
| MLE | Enzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control | 1 |
| MVJ | Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 13, 2000 | K003057 | AUTOSTAT II ENA-4 PROFILE ELISA Cogent Diagnotics , Ltd., GB | LLL |
| Oct 13, 2000 | K003054 | AUTOSTAT II ENA-6 PROFILE ELISA Cogent Diagnotics , Ltd., GB | LLL |
| Sep 28, 2000 | K002215 | AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISA Cogent Diagnotics , Ltd., GB | MOB |
| Mar 3, 2000 | K993557 | AUTOSTAT II RHEUMATOID FACTOR IGA ELISA Cogent Diagnotics , Ltd., GB | DHR |
| Feb 3, 2000 | K994338 | AUTOSTAT II RHEUMATOID FACTOR IGM ELISA Cogent Diagnotics , Ltd., GB | DHR |
| Feb 1, 2000 | K993085 | AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISA Cogent Diagnotics , Ltd. | MID |
| Dec 6, 1999 | K993304 | AUTOSTAT II RHEUMATOID FACTOR IGG ELISA Cogent Diagnotics , Ltd., GB | DHR |
| Nov 24, 1999 | K992449 | AUTOSTAT II ANTI-CARDIOLIPIN IGM ELISA Cogent Diagnotics , Ltd., GB | MID |
| Nov 12, 1999 | K993087 | AUTOSTAT II ANTI-GLIADIN IGG ELISA Cogent Diagnotics , Ltd., GB | MST |
| Nov 12, 1999 | K993086 | AUTOSTAT II ANTI-GLIADIN IGA ELISA Cogent Diagnotics , Ltd., GB | MST |
| Sep 21, 1999 | K992440 | AUTOSTAT II ANTI-CARDIOLIPIN IGG ELISA Cogent Diagnotics , Ltd., GB | MID |
| Aug 24, 1999 | K991942 | AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISA Cogent Diagnotics , Ltd., GB | MLE |
| Aug 9, 1999 | K991890 | AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA Cogent Diagnotics , Ltd., GB | MVJ |
| Apr 28, 1999 | K990798 | AUTOSTAT II ANTI-JO-1 ELISA Cogent Diagnotics , Ltd., GB | LLL |
| Apr 28, 1999 | K990797 | AUTOSTAT II ANTI-SCL-70 ELISA Cogent Diagnotics , Ltd., GB | LLL |
| Apr 28, 1999 | K990796 | AUTOSTAT II ANTI-PR 3 (C-ANCA)ELISA, HY*TEC ANTI-PR 3 (C-ANCA)ELISA Cogent Diagnotics , Ltd., GB | MOB |
| Apr 28, 1999 | K990627 | AUTOSTAT II ANTI-SS-A/RO ELISA Cogent Diagnotics , Ltd., GB | LLL |
| Apr 28, 1999 | K990626 | AUTOSTAT II ANTI-SS-B/LA ELISA Cogent Diagnotics , Ltd., GB | LLL |
| Apr 28, 1999 | K990625 | AUTOSTAT II ANTI-SM ELISA Cogent Diagnotics , Ltd., GB | LKP |
| Apr 28, 1999 | K990624 | AUTOSTAT II ANTI-SM/RNP ELISA Cogent Diagnotics , Ltd., GB | LKO |
| Jan 28, 1999 | K983655 | AUTOSTAT II ANA SCREEN ELISA Cogent Diagnotics , Ltd., GB | LJM |
| Dec 28, 1998 | K983921 | AUTOSTAT II ENA SCREEN ELISA Cogent Diagnotics , Ltd., GB | LLL |
| Mar 4, 1997 | K952567 | AUTOSTATTMII ANTI-DSDNA Cogent Diagnotics , Ltd., GB | LRM |
| Apr 17, 1995 | K943580 | AUTOSTAT II ANTI-TPO Cogent Diagnotics , Ltd., GB | JNL |
| Dec 22, 1994 | K943625 | AUTOSTAT II ANTI-THYROGLOBULIN Cogent Diagnotics , Ltd., GB | DDC |
| Mar 22, 1993 | K925783 | AUTOSTAT ANTI-DSDNA Cogent Diagnotics , Ltd., GB | JJX |
| Jan 21, 1993 | K925785 | AUTOSTAT ANTI-THYROID MICROSOMAL KIT Cogent Diagnotics , Ltd., GB | JZO |
| Jan 21, 1993 | K925784 | AUTOSTAT ANTITHYROGLOBIN Cogent Diagnotics , Ltd., GB | JZO |
| Sep 22, 1992 | K923371 | AUTOSTAT ANTI-THYROID MICROSSOMAL Cogent Diagnotics , Ltd., GB | JNL |
| Sep 22, 1992 | K923370 | AUTOSTAT ANTI-THYROGLOBULIN Cogent Diagnotics , Ltd., GB | JNL |
| May 1, 1992 | K913342 | AUTOSTAT(TM) ANTI-DSNA Cogent Diagnotics , Ltd., GB | LKJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||