Cleared Traditional

N ANTISERUM TO HUMAN ALBUMIN

K972929 · Behring Diagnostics, Inc. · Immunology
Oct 1997
Decision
73d
Days
Class 2
Risk

About This 510(k) Submission

K972929 is an FDA 510(k) clearance for the N ANTISERUM TO HUMAN ALBUMIN, a Albumin, Antigen, Antiserum, Control (Class II — Special Controls, product code DCF), submitted by Behring Diagnostics, Inc. (Westwood, US). The FDA issued a Cleared decision on October 20, 1997, 73 days after receiving the submission on August 8, 1997. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5040.

Submission Details

510(k) Number K972929 FDA.gov
FDA Decision Cleared SESE
Date Received August 08, 1997
Decision Date October 20, 1997
Days to Decision 73 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DCF — Albumin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5040

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