Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit— 510(k) K203295
Substantially EquivalentGold Standard Diagnostics
FDA 510(k) clearance K203295 for Gold Standard Diagnostics Borrelia burgdorferi 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.