ADDITIONAL HEMOTEC ACT COAGULATION CARTRIDGES

System, Multipurpose For In Vitro Coagulation Studies

MEDICAL DEVICE CONSULTANTS, INC.

The following data is part of a premarket notification filed by Medical Device Consultants, Inc. with the FDA for Additional Hemotec Act Coagulation Cartridges.

Pre-market Notification Details

Device IDK853198
510k NumberK853198
Device Name:ADDITIONAL HEMOTEC ACT COAGULATION CARTRIDGES
ClassificationSystem, Multipurpose For In Vitro Coagulation Studies
Applicant MEDICAL DEVICE CONSULTANTS, INC. 45 WEST ST. SUITE 2 Attleboro,  MA  02703
ContactWilliam A Morton
CorrespondentWilliam A Morton
MEDICAL DEVICE CONSULTANTS, INC. 45 WEST ST. SUITE 2 Attleboro,  MA  02703
Product CodeJPA  
CFR Regulation Number864.5425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-07-30
Decision Date1985-10-04

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
20643169577484 K853198 000
20613994531821 K853198 000
20613994417286 K853198 000
00763000433833 K853198 000

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