K153145 is an FDA 510(k) clearance for the Lumipulse G TP-N Immunoreaction Cartridge Set. This device is classified as a Enzyme Linked Immunoabsorption Assay, Treponema Pallidum (Class II - Special Controls, product code LIP).
Submitted by Fujirebio Diagnostics,Inc. (Malvern, US). The FDA issued a Cleared decision on July 5, 2016, 249 days after receiving the submission on October 30, 2015.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3830.
| 510(k) Number | K153145 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 30, 2015 |
| Decision Date | July 05, 2016 |
| Days to Decision | 249 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 |