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 |