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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 BK000041
Tradename Viroclear
Device Name Kit, Test(Donors), For Bloodborne Pathogen
Original Applicant
Blackhawk BioSystems,Inc.
12945 alcosta blvd.
san ramon,  CA  94583
Classification Product Code
MYZ  
Date Received10/06/2000
Decision Date 12/28/2000
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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