RESPIRATORY SYNCYTIAL VIRUS CF ANTIGEN & CONTROL

Respiratory Syncytial Virus, Antigen, Antibody, Ifa

SITA, INC.

The following data is part of a premarket notification filed by Sita, Inc. with the FDA for Respiratory Syncytial Virus Cf Antigen & Control.

Pre-market Notification Details

Device IDK872701
510k NumberK872701
Device Name:RESPIRATORY SYNCYTIAL VIRUS CF ANTIGEN & CONTROL
ClassificationRespiratory Syncytial Virus, Antigen, Antibody, Ifa
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 CodeLKT  
CFR Regulation Number866.3480 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-07-07
Decision Date1987-09-18

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