The following data is part of a premarket notification filed by Orion Diagnostica, Inc. with the FDA for Rotalex Latex Agglutination Test.
| Device ID | K841319 |
| 510k Number | K841319 |
| Device Name: | ROTALEX LATEX AGGLUTINATION TEST |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rotavirus |
| Applicant | ORION DIAGNOSTICA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LIQ |
| CFR Regulation Number | 866.3405 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-04-02 |
| Decision Date | 1984-09-14 |