HEMOTEC ACT HIGH RANGE ACTIVATED CLOTTING TIME

Activated Whole Blood Clotting Time

MEDICAL DEVICE CONSULTANTS, INC.

The following data is part of a premarket notification filed by Medical Device Consultants, Inc. with the FDA for Hemotec Act High Range Activated Clotting Time.

Pre-market Notification Details

Device IDK860122
510k NumberK860122
Device Name:HEMOTEC ACT HIGH RANGE ACTIVATED CLOTTING TIME
ClassificationActivated Whole Blood Clotting Time
Applicant MEDICAL DEVICE CONSULTANTS, INC. 45 WEST ST. SUITE 2 Attleboro,  MA  02703
ContactWilliam Morton
CorrespondentWilliam Morton
MEDICAL DEVICE CONSULTANTS, INC. 45 WEST ST. SUITE 2 Attleboro,  MA  02703
Product CodeJBP  
CFR Regulation Number864.7140 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-01-14
Decision Date1986-04-04

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