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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name single (specified) analyte controls (assayed and unassayed)
510(k) Number K121084
Device Name LOCI CARDIAC TROPONIN-I CONTROL (LOW), LCTNI CON L
Original Applicant
SIEMENS HEALTHCARE DIAGNOSTICS INC.
po box 6101
mailstop 514
newark,  DE  19714 6101
Original Contact frances a dillon
Regulation Number862.1660
Classification Product Code
JJX  
Date Received04/10/2012
Decision Date 05/09/2012
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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