The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for Ebna Igg Elisa Test System.
| Device ID | K932742 |
| 510k Number | K932742 |
| Device Name: | EBNA IGG ELISA TEST SYSTEM |
| Classification | Test, Antigen, Nuclear, 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 | LLM |
| CFR Regulation Number | 866.3235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-08 |
| Decision Date | 1995-05-05 |