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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Devices Detecting Influenza A, B, And C Virus Antigens
510(k) Number K092423
Device Name XPECT FLU A & B
Applicant
Thermo Fisher Scientific
12150 Santa Fe Dr.
Lenexa,  KS  66215
Applicant Contact MARY A SILVIUS
Correspondent
Thermo Fisher Scientific
12150 Santa Fe Dr.
Lenexa,  KS  66215
Correspondent Contact MARY A SILVIUS
Regulation Number866.3328
Classification Product Code
PSZ  
Date Received08/07/2009
Decision Date 08/26/2009
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
Predetermined Change
Control Plan Authorized		 No
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