AUTOSTAT(TM) ANTI-DSNA

Antinuclear Antibody, Antigen, Control

COGENT DIAGNOTICS LTD.

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

Pre-market Notification Details

Device IDK913342
510k NumberK913342
Device Name:AUTOSTAT(TM) ANTI-DSNA
ClassificationAntinuclear Antibody, Antigen, Control
Applicant COGENT DIAGNOTICS LTD. ALLANWATER BUSINESS CENTRE STIRLING ROAD Dunblane, Fk15 9ep,  GB
ContactMcgregor
CorrespondentMcgregor
COGENT DIAGNOTICS LTD. ALLANWATER BUSINESS CENTRE STIRLING ROAD Dunblane, Fk15 9ep,  GB
Product CodeLKJ  
CFR Regulation Number866.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-07-26
Decision Date1992-05-01

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