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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name nucleic acid detection system for non-viral microorganism(s) causing sexually transmitted infections
510(k) Number K200866
Device Name Aptima Combo 2 Assay (Panther System), Aptima Combo 2 Assay (Tigris) System)
Applicant
Hologic, Inc.
10210 Genetic Center Drive
san diego,  CA  92121
Applicant Contact anila tarte
Correspondent
Hologic, Inc.
10210 Genetic Center Drive
san diego,  CA  92121
Correspondent Contact anila tarte
Regulation Number866.3393
Classification Product Code
QEP  
Subsequent Product Codes
LSL   MKZ  
Date Received04/01/2020
Decision Date 05/17/2020
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
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