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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 K190515
Device Name Aptima Combo 2 Assay (Panther System)
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
Classification Product Code
QEP  
Subsequent Product Codes
LSL   MKZ  
Date Received03/01/2019
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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