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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name calibrator, multi-analyte mixture
510(k) Number K041870
Device Name N APOLIPOPROTEIN STANDARD SERUM
Original Applicant
DADE BEHRING, INC.
514 gbc dr.
newark,  DE  19702
Original Contact donna a wolf
Regulation Number862.1150
Classification Product Code
JIX  
Date Received07/13/2004
Decision Date 07/27/2004
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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