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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name kit, quality control for blood banking reagents
510(k) Number BK970047
Tradename Olympus System Control Reagent
Device Name Kit, Quality Control for Blood Banking Reagents
Original Applicant
Gamma Biologicals, Inc.
3700 mangum road
houston,  TX  77092
Regulation Number864.9650
Classification Product Code
KSF  
Date Received12/29/1997
Decision Date 12/11/1998
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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