The following data is part of a premarket notification filed by Cogent Diagnotics Ltd. with the FDA for Autostat Ii Anti-tpo.
Device ID | K943580 |
510k Number | K943580 |
Device Name: | AUTOSTAT II ANTI-TPO |
Classification | Immunochemical, Thyroglobulin Autoantibody |
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 | JNL |
CFR Regulation Number | 866.5870 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-07-22 |
Decision Date | 1995-04-17 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00816879020045 | K943580 | 000 |