BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDE— 510(k) K901054

Name: FDA 510(k) clearance K901054
Creator: U.S. Food and Drug Administration
Published: 1990-04-05

Substantially Equivalent

Bion Ent., Ltd.

FDA 510(k) clearance K901054 for BION BORRELIA BURGDORFERI ANTIGEN SUBSTRATE SLIDE, Substantially Equivalent on 1990-04-05. Applicant: Bion Ent., Ltd.. Device class: 2.

Clearance details

Applicant: Bion Ent., Ltd.
Product code: Code LSR
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 1990-03-06
Decision date: 1990-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Park Ridge, IL, US

Download summary PDF View on FDA.gov ↗

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