The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for Zeus Scientific, Inc., Athena Multi-lyte Mmrv Igg Test System..
| Device ID | K051484 |
| 510k Number | K051484 |
| Device Name: | ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MMRV IGG TEST SYSTEM. |
| Classification | Enzyme Linked Immunoabsorbent Assay, Varicella-zoster |
| Applicant | ZEUS SCIENTIFIC, INC. 200 EVANS WAY Branchburg, NJ 08876 |
| Contact | Mark K Kopnitsky |
| Correspondent | Mark K Kopnitsky ZEUS SCIENTIFIC, INC. 200 EVANS WAY Branchburg, NJ 08876 |
| Product Code | LFY |
| CFR Regulation Number | 866.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-06 |
| Decision Date | 2005-12-05 |