Cleared Traditional

RHIGENE HEP-ANA TEST SYSTEM

K042680 · Corgenix, Inc. · Immunology

Nov 2004

Decision

51d

Days

Class 2

Risk

About This 510(k) Submission

K042680 is an FDA 510(k) clearance for the RHIGENE HEP-ANA TEST SYSTEM, a Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (Class II — Special Controls, product code DHN), submitted by Corgenix, Inc. (Des Plaines, US). The FDA issued a Cleared decision on November 19, 2004, 51 days after receiving the submission on September 29, 2004. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number	K042680 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 29, 2004
Decision Date	November 19, 2004
Days to Decision	51 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF

Device Classification

Product Code	DHN — Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 866.5100