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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 K982429
Device Name ZSTATFLU 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 Number866.3328
Classification Product Code
PSZ  
Date Received07/13/1998
Decision Date 08/25/1998
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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