Cleared Traditional

SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS COMPLEMENT C4 (C4) REAGENT, SYNCHRON LX SYSTEMS CALI

K032035 · Beckman Coulter, Inc. · Immunology
Aug 2003
Decision
37d
Days
Class 2
Risk

About This 510(k) Submission

K032035 is an FDA 510(k) clearance for the SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS COMPLEMENT C4 (C4) REAGENT, SYNCHRON LX SYSTEMS CALI, a Complement C3, Antigen, Antiserum, Control (Class II — Special Controls, product code CZW), submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on August 7, 2003, 37 days after receiving the submission on July 1, 2003. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5240.

Submission Details

510(k) Number K032035 FDA.gov
FDA Decision Cleared SESE
Date Received July 01, 2003
Decision Date August 07, 2003
Days to Decision 37 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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