IMMUNODOT BORRELIA (LYME) TEST— 510(k) K911627

Name: FDA 510(k) clearance K911627
Creator: U.S. Food and Drug Administration
Published: 1992-04-08

Substantially Equivalent

General Biometrics, Inc.

FDA 510(k) clearance K911627 for IMMUNODOT BORRELIA (LYME) TEST, Substantially Equivalent on 1992-04-08. Applicant: General Biometrics, Inc.. Device class: 2.

Clearance details

Applicant: General Biometrics, Inc.
Product code: Code LSR
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 1991-04-11
Decision date: 1992-04-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, 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 General Biometrics, Inc.

view all

K924843 — IMMUNODOT(R) ENA/DNA AUTOIMMUNITY SCREENING PANEL1992-12-01
K920400 — IMMUNOWELL CARDIOLIPIN ANTIBODY (IGG) TEST1992-08-20
K920401 — IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TEST1992-08-20
K911599 — IMMUNOWELL LYME (P39 RECOMBINANT) TEST1991-12-30
K911590 — IMMUNOWELL BORRELIA (LYME)TEST1991-12-20

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