K091361 is an FDA 510(k) clearance for the IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEM. This device is classified as a Enzyme Linked Immunoabsorption Assay, Treponema Pallidum (Class II - Special Controls, product code LIP).
Submitted by Siemens Healthcare Diagnostics (Suwanee, US). The FDA issued a Cleared decision on December 16, 2009, 222 days after receiving the submission on May 8, 2009.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3830.
| 510(k) Number | K091361 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 08, 2009 |
| Decision Date | December 16, 2009 |
| Days to Decision | 222 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 |