Cleared Traditional

ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA

K163133 · Immco Diagnostics, Inc. · Immunology

Aug 2017

Decision

273d

Days

Class 2

Risk

About This 510(k) Submission

K163133 is an FDA 510(k) clearance for the ImmuLisa Enhanced AMA IgG Antibody ELISA; ImmuLisa Enhanced AMA IgA/IgG/IgM Antibody ELISA, a Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control (Class II — Special Controls, product code DBM), submitted by Immco Diagnostics, Inc. (Clarence, US). The FDA issued a Cleared decision on August 8, 2017, 273 days after receiving the submission on November 8, 2016. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5090.

Submission Details

510(k) Number	K163133 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 08, 2016
Decision Date	August 08, 2017
Days to Decision	273 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF

Device Classification

Product Code	DBM — Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.5090