The following data is part of a premarket notification filed by Cogent Diagnotics Ltd. with the FDA for Autostat Ii Anti-thyroglobulin.
| Device ID | K943625 |
| 510k Number | K943625 |
| Device Name: | AUTOSTAT II ANTI-THYROGLOBULIN |
| Classification | Thyroglobulin, Antigen, Antiserum, Control |
| Applicant | COGENT DIAGNOTICS LTD. KINGS BUILDINGS, WEST MAINS RD Edinburgh, GB Eh9 3jf |
| Contact | Peter Mcgregor |
| Correspondent | Peter Mcgregor COGENT DIAGNOTICS LTD. KINGS BUILDINGS, WEST MAINS RD Edinburgh, GB Eh9 3jf |
| Product Code | DDC |
| CFR Regulation Number | 866.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-26 |
| Decision Date | 1994-12-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816879020038 | K943625 | 000 |