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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
510(k) Number K023369
Device Name ACCESS TOTAL T4 ASSAY
Applicant
Beckman Coulter, Inc.
1000 Lake Hazeltine Dr.
Chaska,  MN  55318 -1084
Applicant Contact DENISE THOMPSON
Correspondent
Beckman Coulter, Inc.
1000 Lake Hazeltine Dr.
Chaska,  MN  55318 -1084
Correspondent Contact DENISE THOMPSON
Regulation Number862.1700
Classification Product Code
KLI  
Subsequent Product Code
JIS  
Date Received10/08/2002
Decision Date 12/09/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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