Cleared Traditional

EUROIMMUN Anti-West Nile Virus ELISA (IgM)

K153308 · Euroimmun Us, Inc. · Microbiology

Aug 2016

Decision

269d

Days

Class 2

Risk

About This 510(k) Submission

K153308 is an FDA 510(k) clearance for the EUROIMMUN Anti-West Nile Virus ELISA (IgM), a Elisa, Antibody, West Nile Virus (Class II — Special Controls, product code NOP), submitted by Euroimmun Us, Inc. (Morris Plains, US). The FDA issued a Cleared decision on August 12, 2016, 269 days after receiving the submission on November 17, 2015. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3940.

Submission Details

510(k) Number	K153308 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 17, 2015
Decision Date	August 12, 2016
Days to Decision	269 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.