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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 K843660
Device Name IN FLUENZA B VIRUS
Applicant
Institute Virion , Ltd.
6605 Ascot Dr.
Oakland,  CA  94611
Applicant Contact LENNETTE MD
Correspondent
Institute Virion , Ltd.
6605 Ascot Dr.
Oakland,  CA  94611
Correspondent Contact LENNETTE MD
Regulation Number866.3330
Classification Product Code
GNX  
Date Received09/17/1984
Decision Date 09/26/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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