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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Respiratory Virus Panel Nucleic Acid Assay System
510(k) Number K172629
Device Name Panther Fusion AdV/hMPV/RV Assay
Applicant
Hologic, Inc.
10210 Genetic Center Dr.
San Diego,  CA  92121
Applicant Contact Anila K Tarte
Correspondent
Hologic, Inc.
10210 Genetic Center Dr.
San Diego,  CA  92121
Correspondent Contact Anila K Tarte
Regulation Number866.3980
Classification Product Code
OCC  
Subsequent Product Codes
OEM   OOI  
Date Received09/01/2017
Decision Date 12/04/2017
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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