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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name test, platelet antibody
510(k) Number BK140163
Tradename PakPlus
Device Name Test, Platelet Antibody Test
Original Applicant
Immucor GTI Diagnostics, Inc.
20925 crossroads circle
waukesha,  WI  53186
Classification Product Code
MYP  
Date Received08/01/2014
Decision Date 04/27/2015
Decision substantially equivalent (SE)
Review Advisory Committee Hematology
Type 510(k) Traditional
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product No
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