BORRELIA BURGDORFERI IGG WESTERN BLOT TEST SYSTEM— 510(k) K991180

Name: FDA 510(k) clearance K991180
Creator: U.S. Food and Drug Administration
Published: 1999-09-03

Substantially Equivalent

Zeus Scientific, Inc.

FDA 510(k) clearance K991180 for BORRELIA BURGDORFERI IGG WESTERN BLOT TEST SYSTEM, Substantially Equivalent on 1999-09-03. Applicant: Zeus Scientific, Inc.. Device class: 2.

Clearance details

Applicant: Zeus Scientific, Inc.
Product code: Code LSR
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 1999-04-08
Decision date: 1999-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branchburg, NJ, US

Download summary PDF View on FDA.gov ↗

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