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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name boxes, view, blood grouping
510(k) Number BK970003
Tradename Gamma-ReACT Reader
Device Name Boxes, View, Blood Grouping
Original Applicant
Gamma Biologicals, Inc.
3700 mangum road
houston,  TX  77092
Regulation Number864.9185
Classification Product Code
KSY  
Date Received02/10/1997
Decision Date 05/30/1997
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
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 Yes
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