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U.S. Department of Health and Human Services

510(k) Premarket Notification
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New Search Biologics Clearance Letters and 510(k) Summaries Back To Search Results
Device Classification Name centrifuge, blood-bank for in vitro diagnostic use
510(k) Number BK960077
Tradename Gamma Re-ACT Centrifuge
Device Name Blood Bank Centrifuges for In Vitro Diagnostic Use
Original Applicant
Gamma Biologicals, Inc.
3700 mangum road
houston,  TX  77092
Regulation Number864.9275
Classification Product Code
KSO  
Date Received10/15/1996
Decision Date 09/18/1997
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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