Cleared Traditional

BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200

K041658 · Bio-Rad Laboratories, Inc. · Immunology
Dec 2004
Decision
185d
Days
Class 2
Risk

About This 510(k) Submission

K041658 is an FDA 510(k) clearance for the BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200, a Antinuclear Antibody, Antigen, Control (Class II — Special Controls, product code LKJ), submitted by Bio-Rad Laboratories, Inc. (Redmond, US). The FDA issued a Cleared decision on December 20, 2004, 185 days after receiving the submission on June 18, 2004. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number K041658 FDA.gov
FDA Decision Cleared SESE
Date Received June 18, 2004
Decision Date December 20, 2004
Days to Decision 185 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code LKJ — Antinuclear Antibody, Antigen, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5100

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