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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 K191245
Device Name Yumizen C1200 ALP, Yumizen C1200 Albumin
Applicant
HORIBA ABX SAS
Parc Euromedecine
Montpellier Cedex 4,  FR 341184
Applicant Contact Caroline Ferrer
Correspondent
HORIBA ABX SAS
Parc Euromedecine
Montpellier Cedex 4,  FR 341184
Correspondent Contact Caroline Ferrer
Regulation Number862.1050
Classification Product Code
CJE  
Subsequent Product Code
CIX  
Date Received05/09/2019
Decision Date 08/30/2019
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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