HEPTRAC ELECTRONIC QUALITY CONTROL

System, Multipurpose For In Vitro Coagulation Studies

MEDTRONIC BLOOD MANAGEMENT

The following data is part of a premarket notification filed by Medtronic Blood Management with the FDA for Heptrac Electronic Quality Control.

Pre-market Notification Details

Device IDK981815
510k NumberK981815
Device Name:HEPTRAC ELECTRONIC QUALITY CONTROL
ClassificationSystem, Multipurpose For In Vitro Coagulation Studies
Applicant MEDTRONIC BLOOD MANAGEMENT 18501 EAST PLAZA DR. Parker,  CO  80134 -9061
ContactJoyce Thomas
CorrespondentJoyce Thomas
MEDTRONIC BLOOD MANAGEMENT 18501 EAST PLAZA DR. Parker,  CO  80134 -9061
Product CodeJPA  
CFR Regulation Number864.5425 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-05-22
Decision Date1998-07-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00613994615633 K981815 000
00763000014902 K981815 000

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