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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name vaginitis and bacterial vaginosis nucleic acid detection system
510(k) Number K190452
Device Name Aptima BV Assay
Applicant
Hologic, Inc.
10210 Genetic Center Drive
san diego,  CA  92121
Applicant Contact jeffrey hergesheimer
Correspondent
Hologic, Inc.
10210 Genetic Center Drive
san diego,  CA  92121
Correspondent Contact jeffrey hergesheimer
Regulation Number866.3975
Classification Product Code
PQA  
Subsequent Product Codes
NSU   PMN  
Date Received02/25/2019
Decision Date 05/23/2019
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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