K180264 is an FDA 510(k) clearance for the Gold Standard Diagnostics Borrelia burgdorferi IgG/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 May 2, 2018, 92 days after receiving the submission on January 30, 2018.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3830.
| 510(k) Number | K180264 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 30, 2018 |
| Decision Date | May 02, 2018 |
| Days to Decision | 92 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 |