N ANTISERUM TO HUMAN TRANSFERRIN

Transferrin, 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 Antiserum To Human Transferrin.

Pre-market Notification Details

Device IDK972840
510k NumberK972840
Device Name:N ANTISERUM TO HUMAN TRANSFERRIN
ClassificationTransferrin, Antigen, Antiserum, Control
Applicant BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood,  MA  02090
ContactRuth Forstadt
CorrespondentRuth Forstadt
BEHRING DIAGNOSTICS, INC. 151 UNIVERSITY AVE. Westwood,  MA  02090
Product CodeDDG  
CFR Regulation Number866.5880 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-08-01
Decision Date1997-10-17
Summary:summary

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