ACCESS THYROGLOBULIN ANITBODY


Device Classification Name

immunochemical, thyroglobulin autoantibody

510(k) Number K112933
Device Name ACCESS THYROGLOBULIN ANITBODY
Applicant
BECKMAN COULTER, INC.
1000 lake hazeltine dr.
chaska, 
MN 
55318 -1084

Applicant Contact geraldine l baglien
Correspondent
BECKMAN COULTER, INC.
1000 lake hazeltine dr.
chaska, 
MN 
55318 -1084

Correspodent Contact geraldine l baglien
Regulation Number 866.5870
Classification Product Code
JNL  
Subsequent Product Code
JIT  
Date Received 10/03/2011
Decision Date 12/27/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

summary

summary

FDA Review Decision Summary
Type Special
Reviewed by Third Party No

Combination Product

No