BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGG— 510(k) K032713

Name: FDA 510(k) clearance K032713
Creator: U.S. Food and Drug Administration
Published: 2003-11-24

Substantially Equivalent

Boston Biomedica, Inc.

FDA 510(k) clearance K032713 for BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGG, Substantially Equivalent on 2003-11-24. Applicant: Boston Biomedica, Inc.. Device class: 2.

Clearance details

Applicant: Boston Biomedica, Inc.
Product code: Code LSR
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 2003-09-02
Decision date: 2003-11-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Bridgewater, MA, 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 Boston Biomedica, Inc.

view all

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