AUTOSTAT II RHEUMATOID FACTOR IGM ELISA

System, Test, Rheumatoid Factor

COGENT DIAGNOTICS LTD.

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

Pre-market Notification Details

Device IDK994338
510k NumberK994338
Device Name:AUTOSTAT II RHEUMATOID FACTOR IGM ELISA
ClassificationSystem, Test, Rheumatoid Factor
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 CodeDHR  
CFR Regulation Number866.5775 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-12-23
Decision Date2000-02-03

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816879020052 K994338 000

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