The following data is part of a premarket notification filed by Orion Corp. with the FDA for Rubalex, Modification.
| Device ID | K912391 |
| 510k Number | K912391 |
| Device Name: | RUBALEX, MODIFICATION |
| Classification | Latex Agglutination Assay, Rubella |
| Applicant | ORION CORP. P.O. BOX 425 20101 Turku, FI |
| Contact | Timo Raines |
| Correspondent | Timo Raines ORION CORP. P.O. BOX 425 20101 Turku, FI |
| Product Code | LQN |
| CFR Regulation Number | 866.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-24 |
| Decision Date | 1992-05-04 |