N LATEX IGA

Iga, 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 Latex Iga.

Pre-market Notification Details

Device IDK952309
510k NumberK952309
Device Name:N LATEX IGA
ClassificationIga, Antigen, Antiserum, Control
Applicant BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood,  MA  02090
ContactNanacy M Johansen
CorrespondentNanacy M Johansen
BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood,  MA  02090
Product CodeCZP  
CFR Regulation Number866.5510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-05-17
Decision Date1995-06-20

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