The following data is part of a premarket notification filed by Ortho Diagnostic Systems, Inc. with the FDA for Rubella Igg Antibody Elisa Test Sys.
| Device ID | K841200 |
| 510k Number | K841200 |
| Device Name: | RUBELLA IGG ANTIBODY ELISA TEST SYS |
| 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 | 1984-03-21 |
| Decision Date | 1984-05-21 |