Cogent Diagnotics, Ltd.
Midlothian Eh26 0pl, GB
Cogent Diagnotics , Ltd. appears in FDA device records in Midlothian Eh26 0pl, GB. FDA records list 31 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 31
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 31 510(k) clearances for Cogent Diagnotics, Ltd. between 1992 and 2000. The busiest year on record is 1999, with 15. The most recent is 2000, with 6.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1992 | 3 |
| 1993 | 3 |
| 1994 | 1 |
| 1995 | 1 |
| 1997 | 1 |
| 1998 | 1 |
| 1999 | 15 |
| 2000 | 6 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K003057 | AUTOSTAT II ENA-4 PROFILE ELISA | LLL | Substantially Equivalent | |
| K003054 | AUTOSTAT II ENA-6 PROFILE ELISA | LLL | Substantially Equivalent | |
| K002215 | AUTOSTAT II ANTI-MYELOPEROXIDASE (MPO) ELISA | MOB | Substantially Equivalent | |
| K993557 | AUTOSTAT II RHEUMATOID FACTOR IGA ELISA | DHR | Substantially Equivalent | |
| K994338 | AUTOSTAT II RHEUMATOID FACTOR IGM ELISA | DHR | Substantially Equivalent | |
| K993085 | AUTOSTAT II ANTI-CARDIOLIPIN SCREEN ELISA | MID | Substantially Equivalent | |
| K993304 | AUTOSTAT II RHEUMATOID FACTOR IGG ELISA | DHR | Substantially Equivalent | |
| K992449 | AUTOSTAT II ANTI-CARDIOLIPIN IGM ELISA | MID | Substantially Equivalent | |
| K993087 | AUTOSTAT II ANTI-GLIADIN IGG ELISA | MST | Substantially Equivalent | |
| K993086 | AUTOSTAT II ANTI-GLIADIN IGA ELISA | MST | Substantially Equivalent | |
| K992440 | AUTOSTAT II ANTI-CARDIOLIPIN IGG ELISA | MID | Substantially Equivalent | |
| K991942 | AUTOSTAT II ANTI-GPC ELISA, HY.TEC ANTI-GPC ELISA | MLE | Substantially Equivalent | |
| K991890 | AUTOSTAT II ANTI-GBM ELISA, HY.TEC ANTI-GMB ELISA | MVJ | Substantially Equivalent | |
| K990798 | AUTOSTAT II ANTI-JO-1 ELISA | LLL | Substantially Equivalent | |
| K990797 | AUTOSTAT II ANTI-SCL-70 ELISA | LLL | Substantially Equivalent | |
| K990796 | AUTOSTAT II ANTI-PR 3 (C-ANCA)ELISA, HY*TEC ANTI-PR 3 (C-ANCA)ELISA | MOB | Substantially Equivalent | |
| K990627 | AUTOSTAT II ANTI-SS-A/RO ELISA | LLL | Substantially Equivalent | |
| K990626 | AUTOSTAT II ANTI-SS-B/LA ELISA | LLL | Substantially Equivalent | |
| K990625 | AUTOSTAT II ANTI-SM ELISA | LKP | Substantially Equivalent | |
| K990624 | AUTOSTAT II ANTI-SM/RNP ELISA | LKO | Substantially Equivalent | |
| K983655 | AUTOSTAT II ANA SCREEN ELISA | LJM | Substantially Equivalent | |
| K983921 | AUTOSTAT II ENA SCREEN ELISA | LLL | Substantially Equivalent | |
| K952567 | AUTOSTATTMII ANTI-DSDNA | LRM | Substantially Equivalent | |
| K943580 | AUTOSTAT II ANTI-TPO | JNL | Substantially Equivalent | |
| K943625 | AUTOSTAT II ANTI-THYROGLOBULIN | DDC | Substantially Equivalent | |
| K925783 | AUTOSTAT ANTI-DSDNA | JJX | Substantially Equivalent | |
| K925785 | AUTOSTAT ANTI-THYROID MICROSOMAL KIT | JZO | Substantially Equivalent | |
| K925784 | AUTOSTAT ANTITHYROGLOBIN | JZO | Substantially Equivalent | |
| K923371 | AUTOSTAT ANTI-THYROID MICROSSOMAL | JNL | Substantially Equivalent | |
| K923370 | AUTOSTAT ANTI-THYROGLOBULIN | JNL | Substantially Equivalent | |
| K913342 | AUTOSTAT(TM) ANTI-DSNA | LKJ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- LRMAnti-Dna Antibody (Enzyme-Labeled), Antigen, Control
- LKOAnti-Rnp Antibody, Antigen And Control
- LKPAnti-Sm Antibody, Antigen And Control
- MSTAntibodies, Gliadin
- LJMAntinuclear Antibody (Enzyme-Labeled), Antigen, Controls
- LKJAntinuclear Antibody, Antigen, Control
- MVJDevices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)
- MLEEnzyme Immunoassay, Antiparietal Cell Antibody, Antigen, Control
- LLLExtractable Antinuclear Antibody, Antigen And Control
- JNLImmunochemical, Thyroglobulin Autoantibody
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- MIDSystem, Test, Anticardiolipin Immunological
- DHRSystem, Test, Rheumatoid Factor
- JZOSystem, Test, Thyroid Autoantibody
- MOBTest System, Antineutrophil Cytoplasmic Antibodies (Anca)
- DDCThyroglobulin, Antigen, Antiserum, Control
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain