K252627 is an FDA 510(k) clearance for the Lyme-ID IgG Test. This device is classified as a Reagent, Borrelia Serological Reagent (Class II - Special Controls, product code LSR).
Submitted by Inanovate, Inc. (Sioux Falls, US). The FDA issued a Cleared decision on November 14, 2025, 86 days after receiving the submission on August 20, 2025.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3830.
| 510(k) Number | K252627 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 20, 2025 |
| Decision Date | November 14, 2025 |
| Days to Decision | 86 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 |