IS BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM— 510(k) K983605

Name: FDA 510(k) clearance K983605
Creator: U.S. Food and Drug Administration
Published: 1998-12-16

Substantially Equivalent

Columbia Bioscience, Inc.

FDA 510(k) clearance K983605 for IS BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM, Substantially Equivalent on 1998-12-16. Applicant: Columbia Bioscience, Inc.. Device class: 2.

Clearance details

Applicant: Columbia Bioscience, Inc.
Product code: Code LSR
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 1998-10-14
Decision date: 1998-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Columbia, MD, US

Download summary PDF View on FDA.gov ↗

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