The following data is part of a premarket notification filed by Ortho Diagnostic Systems, Inc. with the FDA for Ortho*epstein-barr Virus Ea(d+r)-igg Antibody Elis.
| Device ID | K931443 |
| 510k Number | K931443 |
| Device Name: | ORTHO*EPSTEIN-BARR VIRUS EA(D+R)-IGG ANTIBODY ELIS |
| Classification | Epstein-barr Virus, Other |
| Applicant | ORTHO DIAGNOSTIC SYSTEMS, INC. 1125 MARK AVE. Carpinteria, CA 93013 |
| Contact | Kim W Gray |
| Correspondent | Kim W Gray ORTHO DIAGNOSTIC SYSTEMS, INC. 1125 MARK AVE. Carpinteria, CA 93013 |
| Product Code | LSE |
| CFR Regulation Number | 866.3235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-22 |
| Decision Date | 1993-11-05 |