The following data is part of a premarket notification filed by Orion Diagnostica, Inc. with the FDA for Rotalex 2 Latex Agglutination Test For Rotavirus.
| Device ID | K854129 |
| 510k Number | K854129 |
| Device Name: | ROTALEX 2 LATEX AGGLUTINATION TEST FOR ROTAVIRUS |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rotavirus |
| Applicant | ORION DIAGNOSTICA, INC. 71 VERONICA AVE. P.O. BOX 218 Somerset, NJ 08873 |
| Contact | De Marco |
| Correspondent | De Marco ORION DIAGNOSTICA, INC. 71 VERONICA AVE. P.O. BOX 218 Somerset, NJ 08873 |
| Product Code | LIQ |
| CFR Regulation Number | 866.3405 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-09 |
| Decision Date | 1986-01-21 |