Submission Details
| 510(k) Number | K203296 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 09, 2020 |
| Decision Date | March 22, 2021 |
| Days to Decision | 133 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
Cleared
Traditional
Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit
Mar 2021
Decision
133d
Days
Class 2
Risk
About This 510(k) Submission
K203296 is an FDA 510(k) clearance for the Gold Standard Diagnostics Borrelia burgdorferi IgG ELISA Test Kit, a Reagent, Borrelia Serological Reagent (Class II — Special Controls, product code LSR), submitted by Gold Standard Diagnostics (Davis, US). The FDA issued a Cleared decision on March 22, 2021, 133 days after receiving the submission on November 9, 2020. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3830.
Device Classification
| Product Code | LSR — Reagent, Borrelia Serological Reagent |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.3830 |
Manufacturer
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