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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 K991181
Device Name MODIFICATION OF N PROTEIN STANDARD SL
Original Applicant
DADE BEHRING, INC.
p.o. box 6101
newark,  DE  19714 6101
Original Contact carolyn k george
Regulation Number862.1150
Classification Product Code
JIX  
Date Received04/07/1999
Decision Date 06/01/1999
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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