BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM— 510(k) K033083

Name: FDA 510(k) clearance K033083
Creator: U.S. Food and Drug Administration
Published: 2003-11-26

Substantially Equivalent

Trinity Biotech USA

FDA 510(k) clearance K033083 for BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM, Substantially Equivalent on 2003-11-26. Applicant: Trinity Biotech USA. Device class: 2.

Clearance details

Applicant: Trinity Biotech USA
Product code: Code LSR
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 2003-09-29
Decision date: 2003-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jamestown, NY, US

Download summary PDF View on FDA.gov ↗

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