AUTOSTAT II ANTI-TPO

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 Ii Anti-tpo.

Pre-market Notification Details

Device IDK943580
510k NumberK943580
Device Name:AUTOSTAT II ANTI-TPO
ClassificationImmunochemical, Thyroglobulin Autoantibody
Applicant COGENT DIAGNOTICS LTD. KINGS BUILDINGS, WEST MAINS RD Edinburgh,  GB Eh9 3jf
ContactPeter Mcgregor
CorrespondentPeter Mcgregor
COGENT DIAGNOTICS LTD. KINGS BUILDINGS, WEST MAINS RD Edinburgh,  GB Eh9 3jf
Product CodeJNL  
CFR Regulation Number866.5870 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-07-22
Decision Date1995-04-17

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816879020045 K943580 000

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