HEMOTEC CV WHOLE BLOOD COAGULATION CONTROLS

Analyzer, Heparin, Automated

HEMOTEC, INC.

The following data is part of a premarket notification filed by Hemotec, Inc. with the FDA for Hemotec Cv Whole Blood Coagulation Controls.

Pre-market Notification Details

Device IDK854377
510k NumberK854377
Device Name:HEMOTEC CV WHOLE BLOOD COAGULATION CONTROLS
ClassificationAnalyzer, Heparin, Automated
Applicant HEMOTEC, INC. 14 CODDING RD. Attleboro,  MA  02703
ContactWilliam A Morton
CorrespondentWilliam A Morton
HEMOTEC, INC. 14 CODDING RD. Attleboro,  MA  02703
Product CodeJOX  
CFR Regulation Number864.5680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-10-30
Decision Date1985-12-04

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