The following data is part of a premarket notification filed by Ortho Diagnostic Systems, Inc. with the FDA for Ortho Rubella Elisa Test System.
| Device ID | K822342 |
| 510k Number | K822342 |
| Device Name: | ORTHO RUBELLA ELISA TEST SYSTEM |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rubella |
| Applicant | ORTHO DIAGNOSTIC SYSTEMS, INC. 125 MARK AVENUE Carpinteria , CA 93013 - |
| Product Code | LFX |
| CFR Regulation Number | 866.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-08-04 |
| Decision Date | 1983-03-17 |