INNOFLUOR PRIMIDONE

Respiratory Syncytial Virus, Antigen, Antibody, Ifa

INNOTRON DIAGNOSTICS

The following data is part of a premarket notification filed by Innotron Diagnostics with the FDA for Innofluor Primidone.

Pre-market Notification Details

Device IDK844721
510k NumberK844721
Device Name:INNOFLUOR PRIMIDONE
ClassificationRespiratory Syncytial Virus, Antigen, Antibody, Ifa
Applicant INNOTRON DIAGNOSTICS 6-A FARADAY Irvine,  CA  92718
ContactMarija N Valentekov
CorrespondentMarija N Valentekov
INNOTRON DIAGNOSTICS 6-A FARADAY Irvine,  CA  92718
Product CodeLKT  
CFR Regulation Number866.3480 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-12-04
Decision Date1985-01-08

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