K102283 is an FDA 510(k) clearance for the ZEUS SCIENTIFIC, INC. TREPONEMA PALLIDUM IGG TEST SYSTEM. This device is classified as a Enzyme Linked Immunoabsorption Assay, Treponema Pallidum (Class II - Special Controls, product code LIP).
Submitted by Zeus Scientific, Inc. (Branchburg, US). The FDA issued a Cleared decision on February 10, 2011, 182 days after receiving the submission on August 12, 2010.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3830.
| 510(k) Number | K102283 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 12, 2010 |
| Decision Date | February 10, 2011 |
| Days to Decision | 182 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 |