RHIGENE MESACUP-2 TEST RNP, MODEL M7741


Device Classification Name

anti-rnp antibody, antigen and control

510(k) Number K022017
Device Name RHIGENE MESACUP-2 TEST RNP, MODEL M7741
Original Applicant
RHIGENE, INC.
455 state st.,
suite 104
des plaines, 
IL 
60068

Original Contact yusuke kobe
Regulation Number 866.5100
Classification Product Code
LKO  
Date Received 06/20/2002
Decision Date 08/14/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No