The following data is part of a premarket notification filed by Diasorin Molecular Llc with the FDA for Simplexa Flu A/b & Rsv Direct Gen Ii, Simplexa Flu A/b & Rsv Positive Control Pack.
| Device ID | K201505 |
| 510k Number | K201505 |
| Device Name: | Simplexa Flu A/B & RSV Direct Gen II, Simplexa Flu A/B & RSV Positive Control Pack |
| Classification | Respiratory Virus Panel Nucleic Acid Assay System |
| Applicant | DiaSorin Molecular LLC 11331 Valley View Street Cypress, CA 90630 |
| Contact | Sharon Young |
| Correspondent | Sharon Young DiaSorin Molecular LLC 11331 Valley View Street Cypress, CA 90630 |
| Product Code | OCC |
| CFR Regulation Number | 866.3980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-05 |
| Decision Date | 2020-08-22 |