BEHRING NEPHELOMETER II

Igg, Antigen, Antiserum, Control

BEHRING DIAGNOSTICS, INC.

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

Pre-market Notification Details

Device IDK943997
510k NumberK943997
Device Name:BEHRING NEPHELOMETER II
ClassificationIgg, Antigen, Antiserum, Control
Applicant BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood,  MA  02090
ContactNancy M Johansen
CorrespondentNancy M Johansen
BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood,  MA  02090
Product CodeDEW  
Subsequent Product CodeCFQ
Subsequent Product CodeCZP
Subsequent Product CodeDCH
Subsequent Product CodeGTQ
CFR Regulation Number866.5510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-08-16
Decision Date1994-10-03

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00842768012174 K943997 000
00842768012167 K943997 000
00630414002903 K943997 000

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