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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 K171963
Device Name Panther Fusion Flu A/B/RSV Assay, Panther Fusion Universal Fluids Kit, Panther Fusion Assay Fluids I-S Kit, Panther Fusion Specimen Lysis Tubes
Applicant
Hologic, Inc.
10210 Genetic Center Dr.
San Diedgo,  CA  92121
Applicant Contact Ron Domingo
Correspondent
Hologic, Inc.
10210 Genetic Center Dr.
San Diedgo,  CA  92121
Correspondent Contact Ron Domingo
Regulation Number866.3980
Classification Product Code
OCC  
Subsequent Product Code
OOI  
Date Received06/30/2017
Decision Date 09/26/2017
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
Recalls CDRH Recalls
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