The following data is part of a premarket notification filed by Focus Diagnostics with the FDA for Simplexa Hsv 1 & 2 Direct, Simplexa Hsv 1 & 2 Positive Control Pack.
| Device ID | K150962 |
| 510k Number | K150962 |
| Device Name: | Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack |
| Classification | Herpes Simplex Virus Nucleic Acid Amplification Assay |
| Applicant | FOCUS DIAGNOSTICS 11331 VALLEY VIEW STREET Cypress, CA 90630 |
| Contact | Sharon Young |
| Correspondent | Sharon Young FOCUS DIAGNOSTICS 11331 VALLEY VIEW STREET Cypress, CA 90630 |
| Product Code | OQO |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-04-10 |
| Decision Date | 2015-08-28 |
| Summary: | summary |