The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for Athena Multi-lyte Ebv Vca Igm Test System.
| Device ID | K042092 |
| 510k Number | K042092 |
| Device Name: | ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM |
| Classification | Antibody Igm, If, Epstein-barr Virus |
| 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 | LJN |
| CFR Regulation Number | 866.3235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-03 |
| Decision Date | 2005-04-12 |