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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 K160541
Device Name Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi Control
Applicant
Sysmex America, Inc.
577 Aptakisic Rd..
Lincolnshire,  IL  60069
Applicant Contact Michelle Parker
Correspondent
Sysmex America, Inc.
577 Aptakisic Rd..
Lincolnshire,  IL  60069
Correspondent Contact Michelle Parker
Regulation Number862.1690
Classification Product Code
JLW  
Subsequent Product Codes
JIT   JJE   JJY  
Date Received02/26/2016
Decision Date 10/21/2016
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
Predetermined Change
Control Plan Authorized		 No
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