N PROTEIN STANDARS SY

Complement C3, Antigen, Antiserum, Control

BEHRING DIAGNOSTICS, INC.

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

Pre-market Notification Details

Device IDK955857
510k NumberK955857
Device Name:N PROTEIN STANDARS SY
ClassificationComplement C3, Antigen, Antiserum, 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 CodeCZW  
CFR Regulation Number866.5240 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-12-27
Decision Date1996-02-21

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.