The following data is part of a premarket notification filed by Zeus Scientific, Inc. (zeus) with the FDA for Athena Multi-lyte Treponema Pallidum Igg Plus Test System.
| Device ID | K093837 |
| 510k Number | K093837 |
| Device Name: | ATHENA MULTI-LYTE TREPONEMA PALLIDUM IGG PLUS TEST SYSTEM |
| Classification | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum |
| Applicant | ZEUS SCIENTIFIC, INC. (ZEUS) P.O. BOX 38 Raritan, NJ 08869 |
| Contact | Ewa Nadolczak |
| Correspondent | Ewa Nadolczak ZEUS SCIENTIFIC, INC. (ZEUS) P.O. BOX 38 Raritan, NJ 08869 |
| Product Code | LIP |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-15 |
| Decision Date | 2010-10-01 |