AUTOSTAT ANTI-THYROGLOBULIN

Immunochemical, Thyroglobulin Autoantibody

COGENT DIAGNOTICS LTD.

The following data is part of a premarket notification filed by Cogent Diagnotics Ltd. with the FDA for Autostat Anti-thyroglobulin.

Pre-market Notification Details

Device IDK923370
510k NumberK923370
Device Name:AUTOSTAT ANTI-THYROGLOBULIN
ClassificationImmunochemical, Thyroglobulin Autoantibody
Applicant COGENT DIAGNOTICS LTD. ALLANWATER BUSINESS CENTRE STIRLING ROAD Dunblane, Fk15 9ep,  GB
ContactMcgregor
CorrespondentMcgregor
COGENT DIAGNOTICS LTD. ALLANWATER BUSINESS CENTRE STIRLING ROAD Dunblane, Fk15 9ep,  GB
Product CodeJNL  
CFR Regulation Number866.5870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-07-09
Decision Date1992-09-22

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