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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name hsv-1 and hsv-2 cns nucleic-acid based panel
510(k) Number K141458
Device Name SIMPLEXA HSV 1&2 DIRECT/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 Number866.3307
Classification Product Code
PGH  
Date Received06/02/2014
Decision Date 07/01/2014
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
summary summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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