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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 Drive
San Diego,  CA  92121
Applicant Contact Anila K Tarte
Correspondent
Hologic, Inc.
10210 Genetic Center Drive
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
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