Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit— 510(k) K180264
Substantially EquivalentGold Standard Diagnostics
FDA 510(k) clearance K180264 for Gold Standard Diagnostics Borrelia burgdorferi IgG/IgM ELISA Test Kit, Substantially Equivalent on 2018-05-02. Applicant: Gold Standard Diagnostics. Device class: 2.
Clearance details
- Applicant
- Gold Standard Diagnostics
- Product code
- Product 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
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