The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for Zeus Scientific, Inc. Treponema Pallidum Igg Test System.
| Device ID | K102283 |
| 510k Number | K102283 |
| Device Name: | ZEUS SCIENTIFIC, INC. TREPONEMA PALLIDUM IGG TEST SYSTEM |
| Classification | Enzyme Linked Immunoabsorption Assay, Treponema Pallidum |
| Applicant | ZEUS SCIENTIFIC, INC. 200 EVANS WAY Branchburg, NJ 08876 |
| Contact | Ewa Nadolczak |
| Correspondent | Ewa Nadolczak ZEUS SCIENTIFIC, INC. 200 EVANS WAY Branchburg, NJ 08876 |
| Product Code | LIP |
| CFR Regulation Number | 866.3830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-12 |
| Decision Date | 2011-02-10 |
| Summary: | summary |