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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dna-Reagents, Neisseria
510(k) Number K180681
Device Name Aptima Combo 2 Assay (Panther System)
Applicant
Hologic, Inc.
10210 Genetic Center Dr.
San Diego,  CA  92121
Applicant Contact Jeffrey Hergesheimer
Correspondent
Hologic, Inc.
10210 Genetic Center Dr.
San Diego,  CA  92121
Correspondent Contact Jeffrey Hergesheimer
Regulation Number866.3390
Classification Product Code
LSL  
Subsequent Product Code
MKZ  
Date Received03/15/2018
Decision Date 06/13/2018
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
Predetermined Change
Control Plan Authorized		 No
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