Cleared Special

BIOPLEX 2200 EBV IGG AND SYPHILIS IGG

K120439 · Bio-Rad Laboratories, Inc. · Microbiology
Mar 2012
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K120439 is an FDA 510(k) clearance for the BIOPLEX 2200 EBV IGG AND SYPHILIS IGG, a Enzyme Linked Immunoabsorption Assay, Treponema Pallidum (Class II — Special Controls, product code LIP), submitted by Bio-Rad Laboratories, Inc. (Benicia, US). The FDA issued a Cleared decision on March 14, 2012, 30 days after receiving the submission on February 13, 2012. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3830.

Submission Details

510(k) Number K120439 FDA.gov
FDA Decision Cleared SESE
Date Received February 13, 2012
Decision Date March 14, 2012
Days to Decision 30 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LIP — Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3830

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