The following data is part of a premarket notification filed by Focus Diagnostics, Inc. with the FDA for Simplexa Flu A/b & Rsv.
| Device ID | K102170 |
| 510k Number | K102170 |
| Device Name: | SIMPLEXA FLU A/B & RSV |
| Classification | Respiratory Virus Panel Nucleic Acid Assay System |
| Applicant | FOCUS DIAGNOSTICS, INC. 11331 VALLEY VIEW ST Cypress, CA 90630 |
| Contact | Tara Viviani |
| Correspondent | Tara Viviani FOCUS DIAGNOSTICS, INC. 11331 VALLEY VIEW ST 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 | 2010-08-02 |
| Decision Date | 2010-11-24 |
| Summary: | summary |