AUTOSTAT II ANTI-SM ELISA

Anti-sm 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 Anti-sm Elisa.

Pre-market Notification Details

Device IDK990625
510k NumberK990625
Device Name:AUTOSTAT II ANTI-SM ELISA
ClassificationAnti-sm 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 CodeLKP  
CFR Regulation Number866.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-02-25
Decision Date1999-04-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816879020311 K990625 000

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