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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, Cf, Influenza Virus A, B, C
510(k) Number K872693
Device Name INFLUENZA B VIRUS CF ANTIGEN AND CONTROL ANTIGEN
Applicant
Sita, Inc.
Regulatory Affairs Department
130 So. Main St.
Allentown,  NJ  08501
Applicant Contact JANIS F CHARLTON
Correspondent
Sita, Inc.
Regulatory Affairs Department
130 So. Main St.
Allentown,  NJ  08501
Correspondent Contact JANIS F CHARLTON
Regulation Number866.3330
Classification Product Code
GNW  
Date Received07/07/1987
Decision Date 09/18/1987
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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