BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM— 510(k) K033070

Name: FDA 510(k) clearance K033070
Creator: U.S. Food and Drug Administration
Published: 2003-11-26

Substantially Equivalent

Trinity Biotech USA

FDA 510(k) clearance K033070 for BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM, Substantially Equivalent on 2003-11-26. Applicant: Trinity Biotech USA. Device class: 2.

Clearance details

Applicant: Trinity Biotech USA
Product code: Code LSR
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 2003-09-29
Decision date: 2003-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jamestown, NY, US

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 Trinity Biotech USA

view all

K140455 — CAPTIA MEASLES IGM2014-05-22
K033105 — CAPTIA HSV 1 IGG TYPE SPECIFIC ELISA KIT2004-07-13
K033106 — CAPTIA HSV 2 IGG TYPE SPECIFIC ELISA KIT2004-07-13
K033051 — LEGIONELLA PNEUMOPHILA IGG/IGM2003-11-26
K033064 — MYCOPLASMA IGG2003-11-26

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