Cleared Traditional

BIRAMED BIOTECH BORRELIA B31 IGM VIRABLOT

K051169 · Viramed Biotech AG · Microbiology
Aug 2005
Decision
104d
Days
Class 2
Risk

About This 510(k) Submission

K051169 is an FDA 510(k) clearance for the BIRAMED BIOTECH BORRELIA B31 IGM VIRABLOT, 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 11, 2005, 104 days after receiving the submission on April 29, 2005. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3830.

Submission Details

510(k) Number K051169 FDA.gov
FDA Decision Cleared SESE
Date Received April 29, 2005
Decision Date August 11, 2005
Days to Decision 104 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

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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