HEMOTEC ACT I SYSTEM

Activated Whole Blood Clotting Time

HEMOTEC, INC.

The following data is part of a premarket notification filed by Hemotec, Inc. with the FDA for Hemotec Act I System.

Pre-market Notification Details

Device IDK843459
510k NumberK843459
Device Name:HEMOTEC ACT I SYSTEM
ClassificationActivated Whole Blood Clotting Time
Applicant HEMOTEC, INC. 14 CODDING RD. Attleboro,  MA  02703
ContactWilliam A Morton
CorrespondentWilliam A Morton
HEMOTEC, INC. 14 CODDING RD. Attleboro,  MA  02703
Product CodeJBP  
CFR Regulation Number864.7140 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-09-05
Decision Date1984-12-12

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