The following data is part of a premarket notification filed by Orion Diagnostica, Inc. with the FDA for Diarlex Rota-adeno.
| Device ID | K942286 |
| 510k Number | K942286 |
| Device Name: | DIARLEX ROTA-ADENO |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rotavirus |
| Applicant | ORION DIAGNOSTICA, INC. P.O. BOX 83 02101 Espoo, FI |
| Contact | Timo Raines |
| Correspondent | Timo Raines ORION DIAGNOSTICA, INC. P.O. BOX 83 02101 Espoo, FI |
| Product Code | LIQ |
| CFR Regulation Number | 866.3405 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-04-22 |
| Decision Date | 1994-12-14 |