AUTOSTAT II ANTI-GLIADIN IGA ELISA

Antibodies, Gliadin

COGENT DIAGNOTICS LTD.

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

Pre-market Notification Details

Device IDK993086
510k NumberK993086
Device Name:AUTOSTAT II ANTI-GLIADIN IGA ELISA
ClassificationAntibodies, Gliadin
Applicant COGENT DIAGNOTICS LTD. PENTLANDS SCIENCE PARK BUSH LOAN, PENICUIK Midlothian, Scotland,  GB Eh26 Opl
ContactDanielle M Knight
CorrespondentDanielle M Knight
COGENT DIAGNOTICS LTD. PENTLANDS SCIENCE PARK BUSH LOAN, PENICUIK Midlothian, Scotland,  GB Eh26 Opl
Product CodeMST  
CFR Regulation Number866.5750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-09-15
Decision Date1999-11-12

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816879020205 K993086 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.