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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
Applicant
DADE BEHRING, INC.
514 GBC DR.
NEWARK,  DE  19702
Applicant Contact DONNA A WOLF
Correspondent
DADE BEHRING, INC.
514 GBC DR.
NEWARK,  DE  19702
Correspondent Contact DONNA A WOLF
Regulation Number862.1150
Classification Product Code
JIX  
Date Received07/09/2004
Decision Date 07/27/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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