Cleared Traditional

PLATELIA LYME IGG ASSAY

K080012 · Bio-Rad · Microbiology
May 2008
Decision
126d
Days
Class 2
Risk

About This 510(k) Submission

K080012 is an FDA 510(k) clearance for the PLATELIA LYME IGG ASSAY, a Reagent, Borrelia Serological Reagent (Class II — Special Controls, product code LSR), submitted by Bio-Rad (Beverly, US). The FDA issued a Cleared decision on May 8, 2008, 126 days after receiving the submission on January 3, 2008. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3830.

Submission Details

510(k) Number K080012 FDA.gov
FDA Decision Cleared SESE
Date Received January 03, 2008
Decision Date May 08, 2008
Days to Decision 126 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LSR — Reagent, Borrelia Serological Reagent
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3830

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