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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 BK870020
Tradename Amtec Ficin System
Device Name Solution, Stabilized Enzyme
Original Applicant
Amtec Diagnostics International Inc.
1107 ih-45 south
conroe,  TX  77305
Regulation Number864.9400
Classification Product Code
KSK  
Date Received08/03/1987
Decision Date 02/02/1988
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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