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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigens, Ha (Including Ha Control), Influenza Virus A, B, C
510(k) Number K913828
Device Name QTEST INFLUENZA A
Applicant
Bd Becton Dickinson Vacutainer Systems Preanalytic
1 Becton Dr.
Franklin Lakes,  NJ  07417
Applicant Contact J ARNSBERGER
Correspondent
Bd Becton Dickinson Vacutainer Systems Preanalytic
1 Becton Dr.
Franklin Lakes,  NJ  07417
Correspondent Contact J ARNSBERGER
Regulation Number866.3330
Classification Product Code
GNT  
Date Received08/26/1991
Decision Date 09/23/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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