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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 BK040067
Tradename ACCURUN 803 Nucleic Acid Negative Quality Control (HIV, HCV, HBV)
Device Name Single (Specified) Analyte Controls, (Assayed and Unassayed)
Original Applicant
BBI Diagnostics, A SeraCare Company
375 west street
west bridgewater,  MA  02379
Regulation Number862.1660
Classification Product Code
JJX  
Date Received08/23/2004
Decision Date 11/19/2004
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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