K211302 is an FDA 510(k) clearance for the Elecsys Syphilis. This device is classified as a Enzyme Linked Immunoabsorption Assay, Treponema Pallidum (Class II - Special Controls, product code LIP).
Submitted by Roche Diagnostics (Indianapolis, US). The FDA issued a Cleared decision on July 20, 2021, 82 days after receiving the submission on April 29, 2021.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3830.
| 510(k) Number | K211302 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 29, 2021 |
| Decision Date | July 20, 2021 |
| Days to Decision | 82 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | LIP — Enzyme Linked Immunoabsorption Assay, Treponema Pallidum |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3830 |