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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
Predetermined Change
Control Plan Authorized		 No
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