Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit— 510(k) K200025
Substantially EquivalentGold Standard Diagnostics
FDA 510(k) clearance K200025 for Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit, Substantially Equivalent on 2020-04-06. Applicant: Gold Standard Diagnostics. Device class: 2.
Clearance details
- Applicant
- Gold Standard Diagnostics
- Product code
- Code LSR
- Device class
- Class 2
- Regulation
- 21 CFR 866.3830
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Davis, CA, US
Recent devices under product code LSR
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