VARELISA RECOMBI ANA PROFILE, MODEL 18496


Device Classification Name

antinuclear antibody (enzyme-labeled), antigen, controls

510(k) Number K050625
Device Name VARELISA RECOMBI ANA PROFILE, MODEL 18496
Applicant
SWEDEN DIAGNOSTICS (GERMANY) GMBH
munzinger strasse 7
freiburg, 

DE

d-79111

Applicant Contact sabine klugbauer
Correspondent
SWEDEN DIAGNOSTICS (GERMANY) GMBH
munzinger strasse 7
freiburg, 

DE

d-79111

Correspodent Contact sabine klugbauer
Regulation Number 866.5100
Classification Product Code
LJM  
Date Received 03/11/2005
Decision Date 04/26/2005
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No