LSR
- Product code
- LSR
- Device name
- Reagent, Borrelia Serological Reagent
- Device class
- Class 2
- 21 CFR
- 21 CFR 866.3830
- Medical specialty
- Microbiology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 4
- Summaries archived here
- 4 (direct download)
- 510(k) clearances (all years, FDA)
- 112 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (4)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K254295 | 2026-07-10 | Ortho-Clinical Diagnostics, Inc. (Quid | Sofia Lyme FIA; Sofia 2 Campylobacter FIA | |
| K252627 | 2025-11-14 | Inanovate, Inc. | Lyme-ID IgG Test; Bio-ID800 | |
| K242872 | 2025-06-12 | Id-Fish Technology, Inc. | iDart Lyme IgM ImmunoBlot Kit | |
| K233367 | 2024-08-12 | Id-Fish Technology, Inc. | iDart Lyme IgG ImmunoBlot Kit |
Official FDA classification page: LSR
Classification and pathway per current FDA publications. Data from openFDA (CC0).