RHIGENE ANA ELISA TEST SYSTEM, MODEL K7560


Device Classification Name

antinuclear antibody (enzyme-labeled), antigen, controls

510(k) Number K022018
Device Name RHIGENE ANA ELISA TEST SYSTEM, MODEL K7560
Original Applicant
RHIGENE, INC.
455 state st.,
suite 104
des plaines, 
IL 
60068

Original Contact yusuke kobe
Regulation Number 866.5100
Classification Product Code
LJM  
Date Received 06/20/2002
Decision Date 07/05/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

statement

statement

Type Special
Reviewed by Third Party No

Combination Product

No