The following data is part of a premarket notification filed by Focus Diagnostics, Inc. with the FDA for Herpeselect 1 And 2 Plexus Igg, Model Mp0900g.
| Device ID | K062543 |
| 510k Number | K062543 |
| Device Name: | HERPESELECT 1 AND 2 PLEXUS IGG, MODEL MP0900G |
| Classification | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 |
| Applicant | FOCUS DIAGNOSTICS, INC. 10703 PROGRESS WAY Cypress, CA 90630 -4737 |
| Contact | Micheal J Wagner,esq. |
| Correspondent | Micheal J Wagner,esq. FOCUS DIAGNOSTICS, INC. 10703 PROGRESS WAY Cypress, CA 90630 -4737 |
| Product Code | MXJ |
| CFR Regulation Number | 866.3305 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-30 |
| Decision Date | 2007-02-01 |
| Summary: | summary |