N/T PROTEIN CONTROL SL

Multi-analyte Controls, All Kinds (assayed)

BEHRING DIAGNOSTICS, INC.

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

Pre-market Notification Details

Device IDK964065
510k NumberK964065
Device Name:N/T PROTEIN CONTROL SL
ClassificationMulti-analyte Controls, All Kinds (assayed)
Applicant BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood,  MA  02090
ContactLaura Lebarron
CorrespondentLaura Lebarron
BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood,  MA  02090
Product CodeJJY  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-10-10
Decision Date1996-11-06
Summary:summary

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