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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name panels, test, susceptibility, antimicrobial
510(k) Number K123933
Device Name MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - CEFTAROLINE
Original Applicant
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
1584 enterprise blvd.
west sacramento,  CA  95691
Original Contact elisabeth warriner
Regulation Number866.1640
Classification Product Code
LTT  
Subsequent Product Codes
JWY   LRG   LTW  
Date Received12/20/2012
Decision Date 03/14/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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