PLATELET FUNCTION TEST ASSAY CARTRIDGES FOR THE HEPCON HMS

System, Multipurpose For In Vitro Coagulation Studies

MEDTRONIC HEMOTEC, INC.

The following data is part of a premarket notification filed by Medtronic Hemotec, Inc. with the FDA for Platelet Function Test Assay Cartridges For The Hepcon Hms.

Pre-market Notification Details

Device IDK954202
510k NumberK954202
Device Name:PLATELET FUNCTION TEST ASSAY CARTRIDGES FOR THE HEPCON HMS
ClassificationSystem, Multipurpose For In Vitro Coagulation Studies
Applicant MEDTRONIC HEMOTEC, INC. 18501 EAST PLAZA DR. Parker,  CO  80134 -9061
ContactAdrian Wilson
CorrespondentAdrian Wilson
MEDTRONIC HEMOTEC, INC. 18501 EAST PLAZA DR. Parker,  CO  80134 -9061
Product CodeJPA  
CFR Regulation Number864.5425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-09-07
Decision Date1996-06-20
Summary:summary

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