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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 K950838
Device Name VIRAZYME CULTURE CONFIRMATION SCREEN FOR INFLUENZA AND PARAINFLUENZA VIRUSES
Applicant
ZYMETX, INC.
25 NORTHWEST 4TH ST.
oklahoma city,  OK  73102
Applicant Contact craig d shimasaki
Correspondent
ZYMETX, INC.
25 NORTHWEST 4TH ST.
oklahoma city,  OK  73102
Correspondent Contact craig d shimasaki
Regulation Number866.3330
Classification Product Code
GNT  
Date Received02/24/1995
Decision Date 06/17/1996
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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