BORRELIA BURGDORFERI IGG BLOT TEST— 510(k) K113847
Substantially EquivalentGold Standard Diagnostics
FDA 510(k) clearance K113847 for BORRELIA BURGDORFERI IGG BLOT TEST, Substantially Equivalent on 2012-04-11. 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.