The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for Athena Multi-lyte Rubella Igg Test System.
| Device ID | K063186 |
| 510k Number | K063186 |
| Device Name: | ATHENA MULTI-LYTE RUBELLA IGG TEST SYSTEM |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rubella |
| Applicant | ZEUS SCIENTIFIC, INC. P.O. BOX 38 Raritan, NJ 08869 |
| Contact | Ewa Nadolczak |
| Correspondent | Ewa Nadolczak ZEUS SCIENTIFIC, INC. P.O. BOX 38 Raritan, NJ 08869 |
| Product Code | LFX |
| CFR Regulation Number | 866.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-20 |
| Decision Date | 2007-03-21 |