N/T RHEUMATOLOGY CONTROL SL/1 AND SL/2

C-reactive Protein, Antigen, Antiserum, And Control

BEHRING DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for N/t Rheumatology Control Sl/1 And Sl/2.

Pre-market Notification Details

Device IDK962373
510k NumberK962373
Device Name:N/T RHEUMATOLOGY CONTROL SL/1 AND SL/2
ClassificationC-reactive Protein, Antigen, Antiserum, And Control
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 CodeDCK  
Subsequent Product CodeDHR
Subsequent Product CodeGTQ
CFR Regulation Number866.5270 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-06-20
Decision Date1996-07-11
Summary:summary

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