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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 media, potentiating for in vitro diagnostic use
510(k) Number BK910001
Tradename Gamma Peg
Device Name Media, Potentiating for In Vitro Diagnostic Use
Original Applicant
Gamma Biologicals, Inc.
3700 mangum road
houston,  TX  77092
Regulation Number864.9600
Classification Product Code
KSG  
Date Received01/23/1991
Decision Date 03/24/1992
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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