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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic Esterase--Oxidase, Cholesterol
510(k) Number K111753
Device Name HITACHI CLINICAL ANALYZER S TEST REAGENT CATRIDGE FOR: CHOLESTROL, HDL, LDL, AND TRIGLYCERIDE
Applicant
Hitachi Chemical Diagnostics, Inc.
575 Shirlynn Court
Los Angeles,  CA  94022
Applicant Contact ERIKA B AMMIRATI, RAC, MT (ASCP)
Correspondent
Hitachi Chemical Diagnostics, Inc.
575 Shirlynn Court
Los Angeles,  CA  94022
Correspondent Contact ERIKA B AMMIRATI, RAC, MT (ASCP)
Regulation Number862.1175
Classification Product Code
CHH  
Subsequent Product Codes
CDT   JJE   LBS   MRR  
Date Received06/22/2011
Decision Date 12/14/2011
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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