BORRELIA BURGDORFERI POLYVAL IGG/IGM ANTIBODY TEST— 510(k) K911145

Name: FDA 510(k) clearance K911145
Creator: U.S. Food and Drug Administration
Published: 1991-05-10

Substantially Equivalent

Medical Diagnostic Technologies, Inc.

FDA 510(k) clearance K911145 for BORRELIA BURGDORFERI POLYVAL IGG/IGM ANTIBODY TEST, Substantially Equivalent on 1991-05-10. Applicant: Medical Diagnostic Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Medical Diagnostic Technologies, Inc.
Product code: Product code LSR
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 1991-03-01
Decision date: 1991-05-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Augusta, GA, US

Download summary PDF View on FDA.gov ↗

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