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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name kit, test (donors), for bloodborne pathogen
510(k) Number BK040060
Tradename VeriSure Pro External Quality Controls
Device Name Kit, Test(Donors), For Bloodborne Pathogen
Original Applicant
AcroMetrix Corporation
6058 egret court
benicia,  CA  94510
Classification Product Code
MYZ  
Date Received07/07/2004
Decision Date 05/03/2005
Decision substantially equivalent (SE)
Review Advisory Committee Immunology
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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