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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigens, Cf (Including Cf Control), Influenza Virus A, B, C
510(k) Number K131804
Device Name REMEL XPECT FLU A&B
Applicant
Remel, Inc.
12076 Santa Fe Trail Dr.
Lenexa,  KS  66215
Applicant Contact CINDY KNAPP
Correspondent
Remel, Inc.
12076 Santa Fe Trail Dr.
Lenexa,  KS  66215
Correspondent Contact CINDY KNAPP
Regulation Number866.3330
Classification Product Code
GNX  
Date Received06/19/2013
Decision Date 07/12/2013
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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