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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 single (specified) analyte controls (assayed and unassayed)
510(k) Number BK060064
Tradename VeriSure Pro HBV DNA External Quality Control
Device Name Single (Specified) Analyte Controls, (Assayed and Unassayed)
Original Applicant
AcroMetrix Corporation
6058 egret court
benicia,  CA  94510
Regulation Number862.1660
Classification Product Code
JJX  
Date Received12/21/2006
Decision Date 02/08/2007
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
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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