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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay, thyroid-stimulating hormone
510(k) Number K153651
Device Name Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems
Applicant
BECKMAN COULTER, INC.
Immunodiagnostic Development Center
1000 LAKE HAZELTINE DRIVE
CHASKA,  MN  55318 -1361
Applicant Contact MICHAEL ROBERT LORENZ
Correspondent
BECKMAN COULTER, INC.
Immunodiagnostic Development Center
1000 LAKE HAZELTINE DRIVE
CHASKA,  MN  55318 -1361
Correspondent Contact MICHAEL ROBERT LORENZ
Regulation Number862.1690
Classification Product Code
JLW  
Subsequent Product Code
JIS  
Date Received12/21/2015
Decision Date 08/18/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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