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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 K153219
Device Name ProFlu+ Assay
Applicant
HOLOGIC, INC.
10210 GENETIC CENTER DRIVE
SAN DIEGO,  CA  92121
Applicant Contact RON DOMINGO
Correspondent
HOLOGIC, INC.
10210 GENETIC CENTER DRIVE
SAN DIEGO,  CA  92121
Correspondent Contact RON DOMINGO
Regulation Number866.3980
Classification Product Code
OCC  
Date Received11/05/2015
Decision Date 11/20/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
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