RHIGENE MESACUP2 TEST- SCL-70


information about

Device Classification Name

extractable antinuclear antibody, antigen and control

510(k) Number K000750
Device Name RHIGENE MESACUP2 TEST- SCL-70
Original Applicant
RHIGENE, INC.
455 state st.,
suite 104
des plaines, 
IL 
60068

Original Contact dave kolesar
Regulation Number 866.5100
Classification Product Code
LLL  
Date Received 03/08/2000
Decision Date 05/09/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

Type Traditional
Reviewed by Third Party No

Combination Product

No