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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 solution, stabilized enzyme
510(k) Number BK880016
Tradename GammaZyme-B
Device Name Solution, Stabilized Enzyme
Original Applicant
Gamma Biologicals, Inc.
3700 mangum road
houston,  TX  77092
Regulation Number864.9400
Classification Product Code
KSK  
Date Received06/15/1988
Decision Date 08/25/1988
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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