EL-ANA PROFILES-2K1


definition

Device Classification Name

antinuclear antibody (enzyme-labeled), antigen, controls

510(k) Number K002559
Device Name EL-ANA PROFILES-2K1
Original Applicant
THERATEST LABORATORIES, INC.
2201 west campbell park dr.
chicago, 
IL 
60612 -3501

Original Contact marius teodorescu
Regulation Number 866.5100
Classification Product Code
LJM  
Date Received 08/17/2000
Decision Date 09/12/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

Type Traditional
Reviewed by Third Party No

Combination Product

No