Lyme B. burgdorferi (IgG) MarStripe Test— 510(k) K163095
Substantially EquivalentTrinity Biotech
FDA 510(k) clearance K163095 for Lyme B. burgdorferi (IgG) MarStripe Test, Substantially Equivalent on 2017-02-01. Applicant: Trinity Biotech.
Clearance details
- Applicant
- Trinity Biotech
- Product code
- Code LSR
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Buffalo, NY, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.