Cleared Traditional

EUROIMMUN HIPPOCAMPUS/CEREBELLUM/GLUTAMATE RECEPTOR/IFA BIOCHIP MOSAIC TEST SYSTEM

K100017 · Euroimmun Us, Inc. · Immunology

Sep 2010

Decision

252d

Days

Class 2

Risk

About This 510(k) Submission

K100017 is an FDA 510(k) clearance for the EUROIMMUN HIPPOCAMPUS/CEREBELLUM/GLUTAMATE RECEPTOR/IFA BIOCHIP MOSAIC TEST SYSTEM, a Anti-glutamate Receptor (type Nmda) Ifa (Class II — Special Controls, product code OSK), submitted by Euroimmun Us, Inc. (Morristown, US). The FDA issued a Cleared decision on September 13, 2010, 252 days after receiving the submission on January 4, 2010. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number	K100017 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 04, 2010
Decision Date	September 13, 2010
Days to Decision	252 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF

Device Classification

Product Code	OSK — Anti-glutamate Receptor (type Nmda) Ifa
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.5660
Definition	Intended For The Qualitative Determination Of Autoantibodies Against Glutamate Receptor (type Nmda) In Human Serum. Used As An Aid In The Diagnosis Of Anti-glutamate Receptor (type Nmda) Autoimmune Encephalitis In Conjunction With Other Laboratory And Clinical Findings.