The following data is part of a premarket notification filed by Rheonix, Inc with the FDA for Rheonix Sti Tri-plex Assay, Rheonix Encompassmdx Workstation (instrument And Software), Rheonix Urine Specimen Collection Kit, Rheonix Swab Specimen Collection Kit.
| Device ID | K193081 |
| 510k Number | K193081 |
| Device Name: | Rheonix STI Tri-Plex Assay, Rheonix EncompassMDx Workstation (instrument And Software), Rheonix Urine Specimen Collection Kit, Rheonix Swab Specimen Collection Kit |
| Classification | Nucleic Acid Detection System For Non-viral Microorganism(s) Causing Sexually Transmitted Infections |
| Applicant | Rheonix, Inc 10 Brown Road, Suite 103 Ithaca, NY 14850 |
| Contact | Richard Montagna |
| Correspondent | Richard Montagna Rheonix, Inc 2680 Grand Island Boulevard, Suite 1 Grand Island, NY 14072 |
| Product Code | QEP |
| Subsequent Product Code | LSL |
| Subsequent Product Code | MKZ |
| Subsequent Product Code | NSU |
| Subsequent Product Code | OUY |
| CFR Regulation Number | 866.3393 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-11-05 |
| Decision Date | 2021-12-17 |