LYME-SPOT IF KIT— 510(k) K910230

Substantially Equivalent

Vitek Systems, Inc.

FDA 510(k) clearance K910230 for LYME-SPOT IF KIT, Substantially Equivalent on 1991-08-30. Applicant: Vitek Systems, Inc.. Device class: 2.

Clearance details

Applicant: Vitek Systems, Inc.
Product code: Code LSR
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 1991-01-18
Decision date: 1991-08-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hazelwood, MI, 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 Vitek Systems, Inc.

K920661 — VIDAS CMV IGG ASSAY1993-02-12
K921302 — VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM1992-07-28
K921176 — VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM1992-04-08
K920952 — VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAY1992-04-07
K915884 — VIDAS CHLAMYDIA ASSAY, MODIFICATION1992-03-04

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