Cleared Traditional

PLATELIA LYME IGM

K081362 · Bio-Rad · Microbiology
Jun 2008
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K081362 is an FDA 510(k) clearance for the PLATELIA LYME IGM, 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 June 26, 2008, 42 days after receiving the submission on May 15, 2008. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3830.

Submission Details

510(k) Number K081362 FDA.gov
FDA Decision Cleared SESE
Date Received May 15, 2008
Decision Date June 26, 2008
Days to Decision 42 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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