EUROIMMUN ANTI-LKM-1 ELISA(LGG)


Device Classification Name

autoantibodies,lkm-1(liver/kidney microsome,type 1)

510(k) Number K112223
Device Name EUROIMMUN ANTI-LKM-1 ELISA(LGG)
Applicant
EUROIMMUN US
1100 the american road
morris plains, 
NJ 
07950

Applicant Contact kathryn kohl
Correspondent
EUROIMMUN US
1100 the american road
morris plains, 
NJ 
07950

Correspodent Contact kathryn kohl
Regulation Number 866.5660
Classification Product Code
NBS  
Date Received 08/02/2011
Decision Date 09/11/2012
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