N LATEX RF

System, Test, Rheumatoid Factor

BEHRING DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for N Latex Rf.

Pre-market Notification Details

Device IDK942328
510k NumberK942328
Device Name:N LATEX RF
ClassificationSystem, Test, Rheumatoid Factor
Applicant BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood,  MA  02090
ContactKathleen Dray-lyons
CorrespondentKathleen Dray-lyons
BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood,  MA  02090
Product CodeDHR  
CFR Regulation Number866.5775 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-05-05
Decision Date1994-10-20

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