The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for Ebv-vca-igm Ifa Test System.
| Device ID | K833014 |
| 510k Number | K833014 |
| Device Name: | EBV-VCA-IGM IFA TEST SYSTEM |
| Classification | Antibody Igm, If, Epstein-barr Virus |
| Applicant | ZEUS SCIENTIFIC, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LJN |
| CFR Regulation Number | 866.3235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-06 |
| Decision Date | 1983-12-27 |