The following data is part of a premarket notification filed by Zeus Scientific, Inc. with the FDA for The Aptus (automated) Application Of The Ebv-vca Igm Elisa Test System. An Enzyme Linked Immunosorbent Assay (elisa) Fo.
| Device ID | K983801 |
| 510k Number | K983801 |
| Device Name: | THE APTUS (AUTOMATED) APPLICATION OF THE EBV-VCA IGM ELISA TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA) FO |
| Classification | Epstein-barr Virus, Other |
| 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 | LSE |
| CFR Regulation Number | 866.3235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-28 |
| Decision Date | 1998-12-10 |