Cleared Traditional

N ANTISERUM TO HUMAN TRANSFERRIN

K972840 · Behring Diagnostics, Inc. · Immunology

Oct 1997

Decision

77d

Days

Class 2

Risk

About This 510(k) Submission

K972840 is an FDA 510(k) clearance for the N ANTISERUM TO HUMAN TRANSFERRIN, a Transferrin, Antigen, Antiserum, Control (Class II — Special Controls, product code DDG), submitted by Behring Diagnostics, Inc. (Westwood, US). The FDA issued a Cleared decision on October 17, 1997, 77 days after receiving the submission on August 1, 1997. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5880.

Submission Details

510(k) Number	K972840 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 01, 1997
Decision Date	October 17, 1997
Days to Decision	77 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF