N PROTEIN STRANDARD SL

Calibrator, Multi-analyte Mixture

BEHRING DIAGNOSTICS, INC.

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

Pre-market Notification Details

Device IDK964062
510k NumberK964062
Device Name:N PROTEIN STRANDARD SL
ClassificationCalibrator, Multi-analyte Mixture
Applicant BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood,  MA  02090
ContactLaura Lebarron
CorrespondentLaura Lebarron
BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood,  MA  02090
Product CodeJIX  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-10-10
Decision Date1996-11-21
Summary:summary

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