PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY— 510(k) K981913

Name: FDA 510(k) clearance K981913
Creator: U.S. Food and Drug Administration
Published: 1999-02-12

Substantially Equivalent

Chembio Diagnostic Systems, Inc.

FDA 510(k) clearance K981913 for PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY, Substantially Equivalent on 1999-02-12. Applicant: Chembio Diagnostic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Chembio Diagnostic Systems, Inc.
Product code: Code LSR
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 1998-06-01
Decision date: 1999-02-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stony Brook, 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 Chembio Diagnostic Systems, Inc.

view all

K011550 — HCG STAT PAK ULTRA-FAST2001-08-14
K011551 — SURE CHECK PREGNANCY TEST2001-08-14
K010244 — SURE CHECK OVULATION PREDICTOR2001-05-02
K961965 — SURE CHECK PREGNANCY TEST1996-06-24
K923925 — HCG STAT-PAK1992-12-24

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