INFLUENZA B VIRUS CF ANTIGEN AND CONTROL ANTIGEN

Antisera, Cf, Influenza Virus A, B, C

SITA, INC.

The following data is part of a premarket notification filed by Sita, Inc. with the FDA for Influenza B Virus Cf Antigen And Control Antigen.

Pre-market Notification Details

Device IDK872693
510k NumberK872693
Device Name:INFLUENZA B VIRUS CF ANTIGEN AND CONTROL ANTIGEN
ClassificationAntisera, Cf, Influenza Virus A, B, C
Applicant SITA, INC. REGULATORY AFFAIRS DEPARTMENT 130 SO. MAIN STREET Allentown,  NJ  08501
ContactJanis F Charlton
CorrespondentJanis F Charlton
SITA, INC. REGULATORY AFFAIRS DEPARTMENT 130 SO. MAIN STREET Allentown,  NJ  08501
Product CodeGNW  
CFR Regulation Number866.3330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-07-07
Decision Date1987-09-18

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