PARAINFLUENZA-2-CF ANTIGEN AND CONTROL ANTIGEN

Antisera, Cf, Parainfluenza Virus 1-4

SITA, INC.

The following data is part of a premarket notification filed by Sita, Inc. with the FDA for Parainfluenza-2-cf Antigen And Control Antigen.

Pre-market Notification Details

Device IDK872695
510k NumberK872695
Device Name:PARAINFLUENZA-2-CF ANTIGEN AND CONTROL ANTIGEN
ClassificationAntisera, Cf, Parainfluenza Virus 1-4
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 CodeGQT  
CFR Regulation Number866.3400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-07-07
Decision Date1987-09-18

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