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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name calibrator, secondary
510(k) Number K082680
Device Name LOCI N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE CALIBRATOR, MODEL RC623
Original Applicant
SIEMENS HEALTHCARE DIAGNOSTICS
ms 514, po box 6101
newark,  DE  19714 6101
Original Contact victor m carrio
Regulation Number862.1150
Classification Product Code
JIT  
Date Received09/15/2008
Decision Date 10/10/2008
Decision substantially equivalent (SE)
Classification Advisory Committee Clinical Chemistry
Review Advisory Committee Clinical Chemistry
summary summary
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
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