IMMUNO DOT BORRELIA DOT BLOT G TEST— 510(k) K953682

Substantially Equivalent

Genbio

FDA 510(k) clearance K953682 for IMMUNO DOT BORRELIA DOT BLOT G TEST, Substantially Equivalent on 1996-05-03. Applicant: Genbio. Device class: 2.

Clearance details

Applicant: Genbio
Product code: Product code LSR
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 1995-08-07
Decision date: 1996-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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 Genbio

K010301 — IMMUNOWELL EA (D) IGG TEST2001-06-11
K974226 — IMMUNODOT MONO-G TEST1998-09-22
K974244 — IMMUNODOT MONO-M TEST1998-09-22
K973939 — IMMUNOWELL VCA IGM TEST1998-08-10
K973940 — IMMUNOWELL EBV VCA IGG TEST1998-08-10

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