Cleared Traditional

BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM

K062213 · Bio-Rad Laboratories, Inc. · Microbiology
Dec 2006
Decision
129d
Days
Class 1
Risk

About This 510(k) Submission

K062213 is an FDA 510(k) clearance for the BIOPLEX 2200 EBV IGM PANEL ON BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, a Epstein-barr Virus, Other (Class I — General Controls, product code LSE), submitted by Bio-Rad Laboratories, Inc. (Redmond, US). The FDA issued a Cleared decision on December 8, 2006, 129 days after receiving the submission on August 1, 2006. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3235.

Submission Details

510(k) Number K062213 FDA.gov
FDA Decision Cleared SESE
Date Received August 01, 2006
Decision Date December 08, 2006
Days to Decision 129 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LSE — Epstein-barr Virus, Other
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3235

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