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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
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
Applicant Contact TARA VIVIANI
Correspondent
FOCUS DIAGNOSTICS, INC.
11331 Valley View Street
CYPRESS,  CA  90630
Correspondent 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 (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
Recalls CDRH Recalls
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