The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for Athena Multi-lyte Torch Igg Plus Test System.
| Device ID | K093784 |
| 510k Number | K093784 |
| Device Name: | ATHENA MULTI-LYTE TORCH IGG PLUS TEST SYSTEM |
| Classification | Multiplex Immunoassay For T. Gondii, Rubella, Cytomegalovirus And Herpes Simplex Virus 1 And 2 |
| 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 | OPM |
| Subsequent Product Code | LFZ |
| Subsequent Product Code | LGD |
| Subsequent Product Code | MXJ |
| Subsequent Product Code | MYF |
| CFR Regulation Number | 866.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-09 |
| Decision Date | 2010-07-16 |
| Summary: | summary |