LIP
- Product code
- LIP
- Device name
- Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
- Device class
- Class 2
- 21 CFR
- 21 CFR 866.3830
- Medical specialty
- Microbiology
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 2
- Summaries archived here
- 2 (direct download)
- 510(k) clearances (all years, FDA)
- 35 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (2)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K241427 | 2024-09-06 | Beckman Coulter, Inc. | Access Syphilis | |
| K241534 | 2024-08-28 | Ortho Clinical Diagnostics | VITROS Immunodiagnostic Products Syphilis Reagent Pa… |
Official FDA classification page: LIP
Classification and pathway per current FDA publications. Data from openFDA (CC0).