Cleared Traditional

C1-INHIBITOR MICROTITER ASSAY DEVICE

K003747 · Baxter Healthcare Corp · Immunology

Mar 2001

Decision

105d

Days

Class 2

Risk

About This 510(k) Submission

K003747 is an FDA 510(k) clearance for the C1-INHIBITOR MICROTITER ASSAY DEVICE, a Complement C1 Inhibitor (inactivator), Antigen, Antiserum, Control (Class II — Special Controls, product code DBA), submitted by Baxter Healthcare Corp (Glendale, US). The FDA issued a Cleared decision on March 19, 2001, 105 days after receiving the submission on December 4, 2000. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5250.

Submission Details

510(k) Number	K003747 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 04, 2000
Decision Date	March 19, 2001
Days to Decision	105 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