The following data is part of a premarket notification filed by Inbios Intl., Inc. with the FDA for West Nile Detect Igm Elisa.
| Device ID | K041817 |
| 510k Number | K041817 |
| Device Name: | WEST NILE DETECT IGM ELISA |
| Classification | Elisa, Antibody, West Nile Virus |
| Applicant | INBIOS INTL., INC. 562 1ST. AVE. SOUTH, SUITE 600 Seattle, WA 98104 |
| Contact | Estela I Raychaudhuri |
| Correspondent | Estela I Raychaudhuri INBIOS INTL., INC. 562 1ST. AVE. SOUTH, SUITE 600 Seattle, WA 98104 |
| Product Code | NOP |
| CFR Regulation Number | 866.3940 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-06 |
| Decision Date | 2004-11-19 |