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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name herpes simplex virus nucleic acid amplification assay
510(k) Number K162673
Device Name Aptima Herpes Simplex Viruses 1 & 2 Assay
Applicant
HOLOGIC, INC.
10210 GENETIC CENTER DR.
san diego,  CA  92121
Applicant Contact ron domingo
Correspondent
HOLOGIC, INC.
10210 GENETIC CENTER DR.
san diego,  CA  92121
Correspondent Contact ron domingo
Regulation Number866.3305
Classification Product Code
OQO  
Date Received09/26/2016
Decision Date 06/15/2017
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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