Cleared Traditional

N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4)

K050665 · Dade Behring, Inc. · Immunology
May 2005
Decision
48d
Days
Class 2
Risk

About This 510(k) Submission

K050665 is an FDA 510(k) clearance for the N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4), a Complement C3, Antigen, Antiserum, Control (Class II — Special Controls, product code CZW), submitted by Dade Behring, Inc. (Newark, US). The FDA issued a Cleared decision on May 2, 2005, 48 days after receiving the submission on March 15, 2005. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5240.

Submission Details

510(k) Number K050665 FDA.gov
FDA Decision Cleared SESE
Date Received March 15, 2005
Decision Date May 02, 2005
Days to Decision 48 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code CZW — Complement C3, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5240

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