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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Parainfluenza Multiplex Nucleic Acid Assay
510(k) Number K172282
Device Name Panther Fusion Paraflu Assay
Applicant
Hologic, Inc.
10210 Genetic Center Dr.
San Diedgo,  CA  92121
Applicant Contact Jeffrey Hergesheimer
Correspondent
Hologic, Inc.
10210 Genetic Center Dr.
San Diedgo,  CA  92121
Correspondent Contact Jeffrey Hergesheimer
Regulation Number866.3980
Classification Product Code
OOU  
Subsequent Product Code
OOI  
Date Received07/28/2017
Decision Date 10/23/2017
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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