The following data is part of a premarket notification filed by Focus Diagnostics, Inc. with the FDA for Simplexa Flu A/b & Rsv Direct, Simplexa Flu A/b & Rsv Positive Control Pack.
| Device ID | K120413 |
| 510k Number | K120413 |
| Device Name: | SIMPLEXA FLU A/B & RSV DIRECT, SIMPLEXA FLU A/B & RSV POSITIVE CONTROL PACK |
| Classification | Respiratory Virus Panel Nucleic Acid Assay System |
| Applicant | FOCUS DIAGNOSTICS, INC. 11331 Valley View Street Cypress, CA 90630 |
| Contact | Tara Viviani |
| Correspondent | Tara Viviani FOCUS DIAGNOSTICS, INC. 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 | 2012-02-10 |
| Decision Date | 2012-07-13 |
| Summary: | summary |