The following data is part of a premarket notification filed by Orion Corp. with the FDA for Rubalex (revised Version).
| Device ID | K861881 |
| 510k Number | K861881 |
| Device Name: | RUBALEX (REVISED VERSION) |
| 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 | 1986-05-08 |
| Decision Date | 1986-06-04 |