Cleared Traditional

RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760

K031308 · Rhigene, Inc. · Immunology

Sep 2003

Decision

155d

Days

Class 2

Risk

About This 510(k) Submission

K031308 is an FDA 510(k) clearance for the RHIGENE MESACUP-2 ANTI-MITOCHONDRIA M2 TEST, MODEL 10760, a Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control (Class II — Special Controls, product code DBM), submitted by Rhigene, Inc. (Westminster, US). The FDA issued a Cleared decision on September 26, 2003, 155 days after receiving the submission on April 24, 2003. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5090.

Submission Details

510(k) Number	K031308 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 24, 2003
Decision Date	September 26, 2003
Days to Decision	155 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