Cleared Traditional

VIRAMED BIOTECH AG BORRELIA B31 IGG VIRASTRIPE, MODEL V-BBSGUS

K092693 · Viramed Biotech AG · Microbiology
Nov 2009
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K092693 is an FDA 510(k) clearance for the VIRAMED BIOTECH AG BORRELIA B31 IGG VIRASTRIPE, MODEL V-BBSGUS, 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 November 25, 2009, 84 days after receiving the submission on September 2, 2009. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3830.

Submission Details

510(k) Number K092693 FDA.gov
FDA Decision Cleared SESE
Date Received September 02, 2009
Decision Date November 25, 2009
Days to Decision 84 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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