RUBALEX
Latex Agglutination Assay, Rubella
ORION CORP.
The following data is part of a premarket notification filed by Orion Corp. with the FDA for Rubalex.
Pre-market Notification Details
| Device ID | K852788 |
| 510k Number | K852788 |
| Device Name: | RUBALEX |
| 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 | 1985-07-01 |
| Decision Date | 1986-03-12 |
Trademark Results [RUBALEX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RUBALEX 73508708 1365101 Dead/Cancelled |
ORION-YHTYMA OY 1984-11-14 |
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