The following data is part of a premarket notification filed by Cogent Diagnotics Ltd. with the FDA for Autostat Antithyroglobin.
Device ID | K925784 |
510k Number | K925784 |
Device Name: | AUTOSTAT ANTITHYROGLOBIN |
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 |