Cleared Traditional

WEST NILE VIRUS IGM CAPTURE ELISA, MODEL E-WNV02M

K041231 · Panbio Limited · Microbiology

Aug 2004

Decision

92d

Days

Class 2

Risk

About This 510(k) Submission

K041231 is an FDA 510(k) clearance for the WEST NILE VIRUS IGM CAPTURE ELISA, MODEL E-WNV02M, a Elisa, Antibody, West Nile Virus (Class II — Special Controls, product code NOP), submitted by Panbio Limited (Windsor, AU). The FDA issued a Cleared decision on August 10, 2004, 92 days after receiving the submission on May 10, 2004. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3940.

Submission Details

510(k) Number	K041231 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 10, 2004
Decision Date	August 10, 2004
Days to Decision	92 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Summary PDF

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.