Lyme B. burgdorferi (IgG) MarStripe Test— 510(k) K163095

Name: FDA 510(k) clearance K163095
Creator: U.S. Food and Drug Administration
Published: 2017-02-01

Substantially Equivalent

Trinity Biotech

FDA 510(k) clearance K163095 for Lyme B. burgdorferi (IgG) MarStripe Test, Substantially Equivalent on 2017-02-01. Applicant: Trinity Biotech. Device class: 2.

Clearance details

Applicant: Trinity Biotech
Product code: Code LSR
Device class: Class 2
Regulation: 21 CFR 866.3830
Advisory panel: Microbiology
Date received: 2016-11-04
Decision date: 2017-02-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buffalo, NY, US

Download summary PDF View on FDA.gov ↗

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