The following data is part of a premarket notification filed by Ortho Diagnostic Systems, Inc. with the FDA for Modified Ortho Ebv Vca-igg Elisa.
| Device ID | K920412 |
| 510k Number | K920412 |
| Device Name: | MODIFIED ORTHO EBV VCA-IGG ELISA |
| Classification | Antigen, Ebv, Capsid |
| Applicant | ORTHO DIAGNOSTIC SYSTEMS, INC. 1125 MARK AVE. Carpinteria, CA 93013 |
| Contact | Kin W Gray |
| Correspondent | Kin W Gray ORTHO DIAGNOSTIC SYSTEMS, INC. 1125 MARK AVE. Carpinteria, CA 93013 |
| Product Code | MCD |
| CFR Regulation Number | 866.3235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-31 |
| Decision Date | 1992-06-22 |