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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name immunochemical, thyroglobulin autoantibody
510(k) Number K112933
Device Name ACCESS THYROGLOBULIN ANITBODY
Original Applicant
BECKMAN COULTER, INC.
1000 lake hazeltine dr.
chaska,  MN  55318 -1084
Original Contact geraldine l baglien
Regulation Number866.5870
Classification Product Code
JNL  
Subsequent Product Code
JIT  
Date Received10/03/2011
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
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