Cleared Traditional

EUROIMMUN ANTI BP 180-4X ELISA (IGG)

K083615 · Euroimmun Us, Inc. · Immunology

Mar 2009

Decision

98d

Days

Class 2

Risk

About This 510(k) Submission

K083615 is an FDA 510(k) clearance for the EUROIMMUN ANTI BP 180-4X ELISA (IGG), a Autoantibodies, Skin (bullous Pemphigoid 180 And Bullous Pemphigoid 230 (Class II — Special Controls, product code OEG), submitted by Euroimmun Us, Inc. (Morristown, US). The FDA issued a Cleared decision on March 16, 2009, 98 days after receiving the submission on December 8, 2008. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number	K083615 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 08, 2008
Decision Date	March 16, 2009
Days to Decision	98 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Statement

Device Classification

Product Code	OEG — Autoantibodies, Skin (bullous Pemphigoid 180 And Bullous Pemphigoid 230
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.5660
Definition	The Device Is Intended As An Aid In The Diagnosis Of Bullous Pemphigoid.