The following data is part of a premarket notification filed by Focus Diagnostics with the FDA for Simplexa Hsv 1&2 Direct/positive Control Pack.
| Device ID | K141458 |
| 510k Number | K141458 |
| Device Name: | SIMPLEXA HSV 1&2 DIRECT/POSITIVE CONTROL PACK |
| Classification | Hsv-1 And Hsv-2 Cns Nucleic-acid Based Panel |
| 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 | PGH |
| CFR Regulation Number | 866.3307 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-06-02 |
| Decision Date | 2014-07-01 |
| Summary: | summary |