The following data is part of a premarket notification filed by Cogent Diagnotics Ltd. with the FDA for Autostat Anti-thyroid Microsomal Kit.
| Device ID | K925785 |
| 510k Number | K925785 |
| Device Name: | AUTOSTAT ANTI-THYROID MICROSOMAL KIT |
| Classification | System, Test, Thyroid Autoantibody |
| Applicant | COGENT DIAGNOTICS LTD. ALLANWATER BUSINESS CENTRE STIRLING ROAD Dunblane, Fk15 9ep, GB |
| Contact | Peter Mcgregor |
| Correspondent | Peter Mcgregor COGENT DIAGNOTICS LTD. ALLANWATER BUSINESS CENTRE STIRLING ROAD Dunblane, Fk15 9ep, GB |
| Product Code | JZO |
| CFR Regulation Number | 866.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-03 |
| Decision Date | 1993-01-21 |