AUTOSTAT ANTITHYROGLOBIN

System, Test, Thyroid Autoantibody

COGENT DIAGNOTICS LTD.

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

Pre-market Notification Details

Device IDK925784
510k NumberK925784
Device Name:AUTOSTAT ANTITHYROGLOBIN
ClassificationSystem, Test, Thyroid Autoantibody
Applicant COGENT DIAGNOTICS LTD. ALLANWATER BUSINESS CENTRE STIRLING ROAD Dunblane, Fk15 9ep,  GB
ContactPeter Mcgregor
CorrespondentPeter Mcgregor
COGENT DIAGNOTICS LTD. ALLANWATER BUSINESS CENTRE STIRLING ROAD Dunblane, Fk15 9ep,  GB
Product CodeJZO  
CFR Regulation Number866.5870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-11-03
Decision Date1993-01-21

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