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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diazo Colorimetry, Bilirubin
510(k) Number K131217
Device Name S TEST REAGENT CARTRIDGE TOTAL BILIRUBIN
Applicant
Hitachi Chemical Diagnostics, Inc.
630 Clyde Ct.
Mountain View,  CA  94043
Applicant Contact CHARLES TSOU
Correspondent
Hitachi Chemical Diagnostics, Inc.
630 Clyde Ct.
Mountain View,  CA  94043
Correspondent Contact CHARLES TSOU
Regulation Number862.1110
Classification Product Code
CIG  
Date Received04/30/2013
Decision Date 06/07/2013
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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