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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 K031565
Device Name XPECT INFLUENZA A/B
Applicant
Remel, Inc.
12076 Santa Fe Dr.
Lenexa,  KS  66215
Applicant Contact MARY ANN SILVIUS
Correspondent
Remel, Inc.
12076 Santa Fe Dr.
Lenexa,  KS  66215
Correspondent Contact MARY ANN SILVIUS
Regulation Number866.3328
Classification Product Code
PSZ  
Date Received05/19/2003
Decision Date 07/17/2003
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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