N ANTISERUM TO HUMAN ALBUMIN

Albumin, 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 Albumin.

Pre-market Notification Details

Device IDK972929
510k NumberK972929
Device Name:N ANTISERUM TO HUMAN ALBUMIN
ClassificationAlbumin, 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 CodeDCF  
CFR Regulation Number866.5040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-08-08
Decision Date1997-10-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00842768038020 K972929 000
00842768038013 K972929 000

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