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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name myoglobin, antigen, antiserum, control
510(k) Number K122599
Device Name ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR
Original Applicant
SIEMENS HEALTHCARE DIAGNOSTICS INC.
511 benedict ave.
tarrytown,  NY  10591
Original Contact kira gordon
Regulation Number866.5680
Classification Product Code
DDR  
Subsequent Product Code
JIT  
Date Received08/27/2012
Decision Date 10/03/2012
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Immunology
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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