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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name antisera, cf, influenza virus a, b, c
510(k) Number K913214
Device Name INFLUENZA MAB TEST/INFLUENZA B TEST
Applicant
GULL LABORATORIES, INC.
1011 east 4800 south
salt lake city,  UT  84117
Applicant Contact fred w rachford
Correspondent
GULL LABORATORIES, INC.
1011 east 4800 south
salt lake city,  UT  84117
Correspondent Contact fred w rachford
Regulation Number866.3330
Classification Product Code
GNW  
Date Received07/19/1991
Decision Date 12/13/1991
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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