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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 K062516
Device Name ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS)
Applicant
Beckman Coulter, Inc.
1000 Lake Hazeltine Dr.
Chaska,  MN  55318 -1084
Applicant Contact TYLER FOUTCH
Correspondent
Beckman Coulter, Inc.
1000 Lake Hazeltine Dr.
Chaska,  MN  55318 -1084
Correspondent Contact TYLER FOUTCH
Regulation Number866.5870
Classification Product Code
JNL  
Subsequent Product Code
JIT  
Date Received08/28/2006
Decision Date 10/05/2006
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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