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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, C-Reactive Protein
510(k) Number K113809
Device Name HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE PROTEIN (CRP)
Applicant
Hitachi Chemical Diagnostics, Inc.
575 Shirlynn Ct.
Los Angeles,  CA  94022
Applicant Contact ERICKA B AMMIRATI
Correspondent
Hitachi Chemical Diagnostics, Inc.
575 Shirlynn Ct.
Los Angeles,  CA  94022
Correspondent Contact ERICKA B AMMIRATI
Regulation Number866.5270
Classification Product Code
DCN  
Date Received12/23/2011
Decision Date 08/17/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
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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