Cleared Traditional

N ANTISERUM TO C1 INHIBITOR

K960257 · Behring Diagnostics, Inc. · Immunology

Aug 1996

Decision

196d

Days

Class 2

Risk

About This 510(k) Submission

K960257 is an FDA 510(k) clearance for the N ANTISERUM TO C1 INHIBITOR, a Complement C1 Inhibitor (inactivator), Antigen, Antiserum, Control (Class II — Special Controls, product code DBA), submitted by Behring Diagnostics, Inc. (Westwood, US). The FDA issued a Cleared decision on August 1, 1996, 196 days after receiving the submission on January 18, 1996. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5250.

Submission Details

510(k) Number	K960257 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 18, 1996
Decision Date	August 01, 1996
Days to Decision	196 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF

Device Classification

Product Code	DBA — Complement C1 Inhibitor (inactivator), Antigen, Antiserum, Control
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.5250