Cleared Traditional

Borrelia B31 ViraChip IgM Test Kit

K163695 · Viramed Biotech AG · Microbiology
Aug 2017
Decision
237d
Days
Class 2
Risk

About This 510(k) Submission

K163695 is an FDA 510(k) clearance for the Borrelia B31 ViraChip IgM 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 August 22, 2017, 237 days after receiving the submission on December 28, 2016. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3830.

Submission Details

510(k) Number K163695 FDA.gov
FDA Decision Cleared SESE
Date Received December 28, 2016
Decision Date August 22, 2017
Days to Decision 237 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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