AUTOSTAT ANTI-DSDNA

Single (specified) Analyte Controls (assayed And Unassayed)

COGENT DIAGNOTICS LTD.

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

Pre-market Notification Details

Device IDK925783
510k NumberK925783
Device Name:AUTOSTAT ANTI-DSDNA
ClassificationSingle (specified) Analyte Controls (assayed And Unassayed)
Applicant COGENT DIAGNOTICS LTD. ALLANWATER BUSINESS CENTRE STIRLING ROAD Dunblane, Fk15 9ep,  GB
ContactPeter Mcgregor
CorrespondentPeter Mcgregor
COGENT DIAGNOTICS LTD. ALLANWATER BUSINESS CENTRE STIRLING ROAD Dunblane, Fk15 9ep,  GB
Product CodeJJX  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-11-02
Decision Date1993-03-22

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