K230863 is an FDA 510(k) clearance for the ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System. This device is classified as a Reagent, Borrelia Serological Reagent (Class II - Special Controls, product code LSR).
Submitted by Zeus Scientific (Branchburg, US). The FDA issued a Cleared decision on July 13, 2023, 106 days after receiving the submission on March 29, 2023.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3830.
| 510(k) Number | K230863 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 29, 2023 |
| Decision Date | July 13, 2023 |
| Days to Decision | 106 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Statement |
| Product Code | LSR - Reagent, Borrelia Serological Reagent |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3830 |