Cleared Traditional

BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEM

K092587 · Bio-Rad Laboratories · Microbiology
Dec 2010
Decision
466d
Days
Class 2
Risk

About This 510(k) Submission

K092587 is an FDA 510(k) clearance for the BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEM, a Enzyme Linked Immunoabsorbent Assay, Rubella (Class II — Special Controls, product code LFX), submitted by Bio-Rad Laboratories (Benicia, US). The FDA issued a Cleared decision on December 3, 2010, 466 days after receiving the submission on August 24, 2009. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3510.

Submission Details

510(k) Number K092587 FDA.gov
FDA Decision Cleared SESE
Date Received August 24, 2009
Decision Date December 03, 2010
Days to Decision 466 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LFX — Enzyme Linked Immunoabsorbent Assay, Rubella
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3510

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