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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 K142365
Device Name Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control Pack
Applicant
FOCUS DIAGNOSTICS
11331 Valley View Street
cypress,  CA  90630
Applicant Contact sharon young
Correspondent
FOCUS DIAGNOSTICS
11331 Valley View Street
cypress,  CA  90630
Correspondent Contact sharon young
Regulation Number866.3980
Classification Product Code
OCC  
Subsequent Product Code
OOI  
Date Received08/25/2014
Decision Date 12/05/2014
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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