VARELISA CARDIOLIPIN ANTIBODIES SCREEN, MODELS 15848 AND 15896


Device Classification Name

system, test, anticardiolipin immunological

510(k) Number K023433
Device Name VARELISA CARDIOLIPIN ANTIBODIES SCREEN, MODELS 15848 AND 15896
Original Applicant
PHARMACIA DIAGNOSTICS GMBH & CO. KG
munzingerstrasse 7
freiburg, 

DE

d-79111

Original Contact michael linss
Regulation Number 866.5660
Classification Product Code
MID  
Date Received 10/15/2002
Decision Date 11/13/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No