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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 K200436
Device Name Aptima Combo 2 Assay (Panther) - 250 test kit, Aptima Combo 2 Assay (Tigris) - 250 test kit, Aptima Trichomonas Vaginalis (Panther) - 250 test kit, Aptima Trichomonas Vaginalis (Tigris) - 250 test kit
Applicant
Hologic, Inc.
10210 Genetic Center Drive
san diego,  CA  92121
Applicant Contact jill wyland
Correspondent
Hologic, Inc.
10210 Genetic Center Drive
san diego,  CA  92121
Correspondent Contact jill wyland
Regulation Number866.3393
Classification Product Code
QEP  
Subsequent Product Codes
LSL   MKZ   OUY  
Date Received02/24/2020
Decision Date 03/23/2020
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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