The following data is part of a premarket notification filed by Focus Diagnostics, Inc. with the FDA for Plexus Ebv Igg Multi-analyte Diagnostics, Model: Mp0500g.
| Device ID | K073382 |
| 510k Number | K073382 |
| Device Name: | PLEXUS EBV IGG MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0500G |
| Classification | Epstein-barr Virus, Other |
| Applicant | FOCUS DIAGNOSTICS, INC. 10703 PROGRESS WAY Cypress, CA 90630 -4737 |
| Contact | Constance Bridges |
| Correspondent | Constance Bridges FOCUS DIAGNOSTICS, INC. 10703 PROGRESS WAY Cypress, CA 90630 -4737 |
| Product Code | LSE |
| CFR Regulation Number | 866.3235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-03 |
| Decision Date | 2008-07-28 |
| Summary: | summary |