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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
510(k) Number K130141
Device Name S TEST REAGENT CARTRIDGE ALP (ALKALINE PHOSPHATASE)
Applicant
Hitachi Chemical Diagnostics, Inc.
630 Clyde Ct.
Mountain View,  CA  94043
Applicant Contact ERIKA B AMMIRATI, RAC, MT (ASCP)
Correspondent
Hitachi Chemical Diagnostics, Inc.
630 Clyde Ct.
Mountain View,  CA  94043
Correspondent Contact ERIKA B AMMIRATI, RAC, MT (ASCP)
Regulation Number862.1050
Classification Product Code
CJE  
Date Received01/22/2013
Decision Date 03/22/2013
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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