Borrelia B31 ViraChip IgM Test Kit— 510(k) K163695

Name: FDA 510(k) clearance K163695
Creator: U.S. Food and Drug Administration
Published: 2017-08-22

Substantially Equivalent

Viramed Biotech AG

FDA 510(k) clearance K163695 for Borrelia B31 ViraChip IgM Test Kit, Substantially Equivalent on 2017-08-22. Applicant: Viramed Biotech AG. Device class: 2.

Clearance details

Applicant: Viramed Biotech AG
Product code: Code LSR
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 2016-12-28
Decision date: 2017-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Planegg, DE

Download summary PDF View on FDA.gov ↗

Recent devices under product code LSR

view all

K254295 — Sofia Lyme FIA; Sofia 2 Campylobacter FIA2026-07-10
K252627 — Lyme-ID IgG Test; Bio-ID8002025-11-14
K242872 — iDart Lyme IgM ImmunoBlot Kit2025-06-12
K233367 — iDart Lyme IgG ImmunoBlot Kit2024-08-12
K230863 — ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit2023-07-13

More clearances from Viramed Biotech AG

view all

K220016 — Viramed Borrela All-In-One ViraChip Test Kit2022-08-19
K163504 — Borrelia B31 ViraChip IgG Test Kit2017-07-12
K092693 — VIRAMED BIOTECH AG BORRELIA B31 IGG VIRASTRIPE, MODEL V-BBSGUS2009-11-25
K082329 — VIRAMED BIOTECH AG BORRELIA B31 IGM VIRASTRIPE2009-08-05
K051071 — VIRAMED BIOTECH BORRELIA B31 IGG VIRABLOT2005-08-11

Data sourced from openFDA. This site is unofficial and independent of the FDA.