Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit— 510(k) K203289
Substantially EquivalentGold Standard Diagnostics
FDA 510(k) clearance K203289 for Gold Standard Diagnostics Borrelia burgdorferi VlsE-OspC IgG/IgM ELISA Test Kit, Substantially Equivalent on 2021-03-22. Applicant: Gold Standard Diagnostics.
Clearance details
- Applicant
- Gold Standard Diagnostics
- Product code
- Code LSR
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Davis, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.