Cleared Traditional

ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250

K141375 · Phadia US, Inc. · Immunology

Feb 2015

Decision

262d

Days

Class 2

Risk

About This 510(k) Submission

K141375 is an FDA 510(k) clearance for the ELIA M2; IMMUNOASSAY, POSITIVE CONTROL 100, POSITIVE CONTROL 250, a Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control (Class II — Special Controls, product code DBM), submitted by Phadia US, Inc. (Freiburg Im Breisgau, DE). The FDA issued a Cleared decision on February 13, 2015, 262 days after receiving the submission on May 27, 2014. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5090.

Submission Details

510(k) Number	K141375 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 27, 2014
Decision Date	February 13, 2015
Days to Decision	262 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