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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name kit, quality control for blood banking reagents
510(k) Number BK010038
Tradename Accurun 1 Multimarker Negative Control
Device Name Kit, Quality Control for Blood Banking Reagents
Original Applicant
BBI Diagnostics, A SeraCare Company
375 west street
west bridgewater,  MA  02379
Regulation Number864.9650
Classification Product Code
KSF  
Date Received09/19/2001
Decision Date 12/18/2001
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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