AUTOSTAT II ENA-6 PROFILE 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-6 Profile Elisa.

Pre-market Notification Details

Device IDK003054
510k NumberK003054
Device Name:AUTOSTAT II ENA-6 PROFILE ELISA
ClassificationExtractable Antinuclear Antibody, Antigen And Control
Applicant COGENT DIAGNOTICS LTD. PENTLANDS SCIENCE PARK BUSH LOAN, PENICUIK Midlothian, Scotland,  GB Eh26 Opl
ContactDanielle Knight
CorrespondentDanielle 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 Received2000-10-02
Decision Date2000-10-13

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816879020380 K003054 000

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