The following data is part of a premarket notification filed by Focus Technologies, Inc. with the FDA for West Nile Virus Elisa Igg, Model El0300g.
| Device ID | K031953 |
| 510k Number | K031953 |
| Device Name: | WEST NILE VIRUS ELISA IGG, MODEL EL0300G |
| Classification | Elisa, Antibody, West Nile Virus |
| 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 | NOP |
| CFR Regulation Number | 866.3940 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-25 |
| Decision Date | 2003-10-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20816101022018 | K031953 | 000 |
| 20816101022001 | K031953 | 000 |
| 10816101022066 | K031953 | 000 |
| 10816101022042 | K031953 | 000 |
| 10816101022318 | K031953 | 000 |
| 10816101022349 | K031953 | 000 |
| 10816101022332 | K031953 | 000 |
| 10816101022325 | K031953 | 000 |