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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name c. difficile nucleic acid amplification test assay
510(K) Number K113433
Device Name SIMPLEXA C. DIFFICILE UNIVERSAL DIRECT
Applicant
FOCUS DIAGNOSTICS, INC.
11331 valley view street
cypress,  CA  90630
Contact sharon young
Regulation Number866.2660
Classification Product Code
OMN  
Date Received11/21/2011
Decision Date 04/04/2012
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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