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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
Predetermined Change
Control Plan Authorized		 No
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