K200023 is an FDA 510(k) clearance for the Gold Standard Diagnostics Borrelia burgdorferi IgM ELISA Test Kit. This device is classified as 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 April 6, 2020, 91 days after receiving the submission on January 6, 2020.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3830.
| 510(k) Number | K200023 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 06, 2020 |
| Decision Date | April 06, 2020 |
| Days to Decision | 91 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LSR - Reagent, Borrelia Serological Reagent |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3830 |