The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for Athena Multi-lyte Ana-ii Test System.
| Device ID | K042416 |
| 510k Number | K042416 |
| Device Name: | ATHENA MULTI-LYTE ANA-II TEST SYSTEM |
| Classification | Antinuclear Antibody, Antigen, Control |
| Applicant | ZEUS SCIENTIFIC, INC. P.O. BOX 38 Raritan, NJ 08869 |
| Contact | Mark J Kopnitsky |
| Correspondent | Mark J Kopnitsky ZEUS SCIENTIFIC, INC. P.O. BOX 38 Raritan, NJ 08869 |
| Product Code | LKJ |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-07 |
| Decision Date | 2004-10-08 |