The following data is part of a premarket notification filed by Focus Technologies, Inc. with the FDA for Herpeselect 1 Elisa Igg, Model El0910g.
| Device ID | K021429 |
| 510k Number | K021429 |
| Device Name: | HERPESELECT 1 ELISA IGG, MODEL EL0910G |
| Classification | Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 |
| Applicant | FOCUS TECHNOLOGIES, INC. 10703 PROGRESS WAY Cypress, CA 90630 -4737 |
| Contact | Michael J Wagner |
| Correspondent | Michael J Wagner FOCUS TECHNOLOGIES, 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 | 2002-05-03 |
| Decision Date | 2002-07-29 |
| Summary: | summary |