Cleared Traditional

WEST NILE DETECT IGM ELISA

K041817 · Inbios Intl., Inc. · Microbiology

Nov 2004

Decision

136d

Days

Class 2

Risk

About This 510(k) Submission

K041817 is an FDA 510(k) clearance for the WEST NILE DETECT IGM ELISA, a Elisa, Antibody, West Nile Virus (Class II — Special Controls, product code NOP), submitted by Inbios Intl., Inc. (Seattle, US). The FDA issued a Cleared decision on November 19, 2004, 136 days after receiving the submission on July 6, 2004. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3940.

Submission Details

510(k) Number	K041817 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 06, 2004
Decision Date	November 19, 2004
Days to Decision	136 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Statement

Device Classification

Product Code	NOP — Elisa, Antibody, West Nile Virus
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.3940
Definition	The West Nile Virus Elisa Is Intended For The Detection Of Igg And Igm Antibodies To West Nile Virus. Specimens May Be Serum Or Cerebral Spinal Fluid From Symptomatic Patients.