Cleared Traditional

Borrelia B31 ViraChip IgG Test Kit

K163504 · Viramed Biotech AG · Microbiology
Jul 2017
Decision
210d
Days
Class 2
Risk

About This 510(k) Submission

K163504 is an FDA 510(k) clearance for the Borrelia B31 ViraChip IgG Test Kit, a Reagent, Borrelia Serological Reagent (Class II — Special Controls, product code LSR), submitted by Viramed Biotech AG (Planegg, DE). The FDA issued a Cleared decision on July 12, 2017, 210 days after receiving the submission on December 14, 2016. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3830.

Submission Details

510(k) Number K163504 FDA.gov
FDA Decision Cleared SESE
Date Received December 14, 2016
Decision Date July 12, 2017
Days to Decision 210 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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