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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic, Carbon-Dioxide
510(k) Number K140248
Device Name S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2)
Applicant
Hitachi Chemical Diagnostics, Inc.
575 Shirlynn Court
Los Angeles,  CA  94022
Applicant Contact ERIKA AMMIRATI
Correspondent
Hitachi Chemical Diagnostics, Inc.
575 Shirlynn Court
Los Angeles,  CA  94022
Correspondent Contact ERIKA AMMIRATI
Regulation Number862.1160
Classification Product Code
KHS  
Date Received01/30/2014
Decision Date 03/11/2014
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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