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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name respiratory virus panel nucleic acid assay system
510(K) Number K120413
Model MOL2650, MOL2660
Device Name SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK
Applicant
FOCUS DIAGNOSTICS, INC.
11331 valley view street
cypress,  CA  90630
Contact tara viviani
Regulation Number866.3980
Classification Product Code
OCC  
Subsequent Product Code
OOI  
Date Received02/10/2012
Decision Date 07/13/2012
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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