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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 K971494
Device Name VIRAZYME INFLUENZA ID TEST FOR INFLUENZA TYPES A AND B VIRUSES
Applicant
ZYMETX, INC.
800 RESEARCH PKWY.
SUITE 100
oklahoma city,  OK  73104
Applicant Contact craig d shimasaki
Correspondent
ZYMETX, INC.
800 RESEARCH PKWY.
SUITE 100
oklahoma city,  OK  73104
Correspondent Contact craig d shimasaki
Regulation Number866.3330
Classification Product Code
GNX  
Date Received04/24/1997
Decision Date 09/10/1997
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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