VIDAS LYME IGG— 510(k) K122986

Substantially Equivalent

Biomerieux S.A.

FDA 510(k) clearance K122986 for VIDAS LYME IGG, Substantially Equivalent on 2013-03-05. Applicant: Biomerieux S.A.. Device class: 2.

Clearance details

Applicant: Biomerieux S.A.
Product code: Code LSR
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 2012-09-26
Decision date: 2013-03-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marcy L Etoile, FR

Download summary PDF View on FDA.gov ↗

Recent devices under product code LSR

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 Biomerieux S.A.

K250274 — ETEST Imipenem/Relebactam P. aeruginosa (IRPA) (0.008/4-128/4 µg/mL)2025-04-30
K210757 — ETEST Fosfomycin (FO) (0.032-512 µg/mL)2021-11-12
K192738 — ETEST Delafloxacin (DFX) (0.002-32 µg/mL)2019-11-26
K192050 — ETEST Eravacycline (ERV) (0.002 32 µg/mL)2019-09-27
K191953 — ETEST Imipenem/Relebactam (IPR) (0.002/4-32/4 ug/mL)2019-08-22

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