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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name urease, photometric, urea nitrogen
510(k) Number K132462
Device Name S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE
Applicant
HITACHI CHEMICAL DIAGNOSTICS, INC.
575 Shirlynn Court
Los Altos,  CA  94022
Applicant Contact ERIKA AMMIRATI
Correspondent
HITACHI CHEMICAL DIAGNOSTICS, INC.
575 Shirlynn Court
Los Altos,  CA  94022
Correspondent Contact ERIKA AMMIRATI
Regulation Number862.1770
Classification Product Code
CDN  
Subsequent Product Code
CGX  
Date Received08/07/2013
Decision Date 10/28/2013
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
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