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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name supplies, blood-bank
510(k) Number BK960090
Tradename Gamma EGA Kit
Device Name Supplies, Blood-Bank
Original Applicant
Gamma Biologicals, Inc.
3700 mangum road
houston,  TX  77092
Regulation Number864.9050
Classification Product Code
KSS  
Date Received11/29/1996
Decision Date 05/19/2025
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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