Cleared Traditional

BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDE

K901054 · Bion Ent., Ltd. · Microbiology
Apr 1990
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K901054 is an FDA 510(k) clearance for the BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDE, a Reagent, Borrelia Serological Reagent (Class II — Special Controls, product code LSR), submitted by Bion Ent., Ltd. (Park Ridge, US). The FDA issued a Cleared decision on April 5, 1990, 30 days after receiving the submission on March 6, 1990. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3830.

Submission Details

510(k) Number K901054 FDA.gov
FDA Decision Cleared SESE
Date Received March 06, 1990
Decision Date April 05, 1990
Days to Decision 30 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code LSR — Reagent, Borrelia Serological Reagent
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3830

Similar Devices — LSR Reagent, Borrelia Serological Reagent

All 110
Lyme-ID IgG Test; Bio-ID800
K252627 · Inanovate, Inc. · Nov 2025
iDart Lyme IgM ImmunoBlot Kit
K242872 · Id-Fish Technology, Inc. · Jun 2025
iDart Lyme IgG ImmunoBlot Kit
K233367 · Id-Fish Technology, Inc. · Aug 2024
ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit
K230863 · Zeus Scientific · Jul 2023
Viramed Borrela All-In-One ViraChip Test Kit
K220016 · Viramed Biotech AG · Aug 2022
Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit
K203289 · Gold Standard Diagnostics · Mar 2021