AUTOSTAT II ENA SCREEN ELISA

Extractable Antinuclear Antibody, Antigen And Control

COGENT DIAGNOTICS LTD.

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

Pre-market Notification Details

Device IDK983921
510k NumberK983921
Device Name:AUTOSTAT II ENA SCREEN ELISA
ClassificationExtractable Antinuclear Antibody, Antigen And Control
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 CodeLLL  
CFR Regulation Number866.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-11-04
Decision Date1998-12-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816879020144 K983921 000

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