ROTALEX
Enzyme Linked Immunoabsorbent Assay, Rotavirus
ORION CORP.
The following data is part of a premarket notification filed by Orion Corp. with the FDA for Rotalex.
Pre-market Notification Details
| Device ID | K860529 |
| 510k Number | K860529 |
| Device Name: | ROTALEX |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rotavirus |
| 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 | LIQ |
| CFR Regulation Number | 866.3405 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-11 |
| Decision Date | 1986-03-04 |
Trademark Results [ROTALEX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ROTALEX 73368695 1270447 Dead/Cancelled |
Orion-yhtyma Oy 1982-06-09 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.