CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZER

Instrument, Coagulation

TEXAS INTL. LABORATORIES, INC.

The following data is part of a premarket notification filed by Texas Intl. Laboratories, Inc. with the FDA for Clot 2 Semiautomatic Coagulation Analyzer.

Pre-market Notification Details

Device IDK900685
510k NumberK900685
Device Name:CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZER
ClassificationInstrument, Coagulation
Applicant TEXAS INTL. LABORATORIES, INC. 50 SARGENT ST. Needham,  MA  02192
ContactRobert P Cogan
CorrespondentRobert P Cogan
TEXAS INTL. LABORATORIES, INC. 50 SARGENT ST. Needham,  MA  02192
Product CodeKQG  
CFR Regulation Number864.5400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-02-12
Decision Date1990-04-16

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