The following data is part of a premarket notification filed by Cogent Diagnotics Ltd. with the FDA for Autostat Anti-thyroglobulin.
Device ID | K923370 |
510k Number | K923370 |
Device Name: | AUTOSTAT ANTI-THYROGLOBULIN |
Classification | Immunochemical, Thyroglobulin Autoantibody |
Applicant | COGENT DIAGNOTICS LTD. ALLANWATER BUSINESS CENTRE STIRLING ROAD Dunblane, Fk15 9ep, GB |
Contact | Mcgregor |
Correspondent | Mcgregor COGENT DIAGNOTICS LTD. ALLANWATER BUSINESS CENTRE STIRLING ROAD Dunblane, Fk15 9ep, GB |
Product Code | JNL |
CFR Regulation Number | 866.5870 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-07-09 |
Decision Date | 1992-09-22 |