Cleared Traditional

K994071 - RHIGENE ANA ELISA TEST SYSTEM
(FDA 510(k) Clearance)

K994071 · Rhigene, Inc. · Immunology

Jan 2000

Decision

47d

Days

Class 2

Risk

K994071 is an FDA 510(k) clearance for the RHIGENE ANA ELISA TEST SYSTEM, a Antinuclear Antibody (enzyme-labeled), Antigen, Controls (Class II — Special Controls, product code LJM), submitted by Rhigene, Inc. (Des Plaines, US). The FDA issued a Cleared decision on January 18, 2000, 47 days after receiving the submission on December 2, 1999. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5100.

Submission Details

510(k) Number	K994071 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 02, 1999
Decision Date	January 18, 2000
Days to Decision	47 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Statement