The following data is part of a premarket notification filed by Focus Diagnostics, Inc. with the FDA for Simplexa Flu A/b & Rsv Direct And Simplexa Flu A/b & Rsv Positive Control Pack.
| Device ID | K152408 |
| 510k Number | K152408 |
| Device Name: | Simplexa Flu A/B & RSV Direct And 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 | Irene M Guzman |
| Correspondent | Irene M Guzman FOCUS DIAGNOSTICS, INC. 11331 VALLEY VIEW STREET Cypress, CA 90630 |
| Product Code | OCC |
| CFR Regulation Number | 866.3980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-25 |
| Decision Date | 2015-09-21 |
| Summary: | summary |