Cleared Traditional

VIRAMED BIOTECH AG BORRELIA B31 IGM VIRASTRIPE

K082329 · Viramed Biotech AG · Microbiology
Aug 2009
Decision
356d
Days
Class 2
Risk

About This 510(k) Submission

K082329 is an FDA 510(k) clearance for the VIRAMED BIOTECH AG BORRELIA B31 IGM VIRASTRIPE, a Reagent, Borrelia Serological Reagent (Class II — Special Controls, product code LSR), submitted by Viramed Biotech AG (Oceanside, US). The FDA issued a Cleared decision on August 5, 2009, 356 days after receiving the submission on August 14, 2008. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3830.

Submission Details

510(k) Number K082329 FDA.gov
FDA Decision Cleared SESE
Date Received August 14, 2008
Decision Date August 05, 2009
Days to Decision 356 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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