Cleared Traditional

EUROIMMUN Anti-BP230-CF ELISA (IgG)

K193115 · Euroimmun Us, Inc. · Immunology

Sep 2020

Decision

310d

Days

Class 2

Risk

About This 510(k) Submission

K193115 is an FDA 510(k) clearance for the EUROIMMUN Anti-BP230-CF ELISA (IgG), a Autoantibodies, Skin (bullous Pemphigoid 180 And Bullous Pemphigoid 230 (Class II — Special Controls, product code OEG), submitted by Euroimmun Us, Inc. (Mountain Lakes, US). The FDA issued a Cleared decision on September 17, 2020, 310 days after receiving the submission on November 12, 2019. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5660.

Submission Details

510(k) Number	K193115 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 12, 2019
Decision Date	September 17, 2020
Days to Decision	310 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.