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

Substantially Equivalent

Trinity Biotech

Clearance details

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

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