COLORSLIDER RUBELLA

Latex Agglutination Assay, Rubella

SERADYN, INC.

The following data is part of a premarket notification filed by Seradyn, Inc. with the FDA for Colorslider Rubella.

Pre-market Notification Details

Device IDK952544
510k NumberK952544
Device Name:COLORSLIDER RUBELLA
ClassificationLatex Agglutination Assay, Rubella
Applicant SERADYN, INC. 1200 MADISON AVE. Indianapolis,  IN  46225
ContactMartin J Weinstein
CorrespondentMartin J Weinstein
SERADYN, INC. 1200 MADISON AVE. Indianapolis,  IN  46225
Product CodeLQN  
CFR Regulation Number866.3510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-06-02
Decision Date1996-01-17

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