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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name enzymatic method, creatinine
510(k) Number K193649
Device Name Yumizen C1200 Creatinine PAP
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 Number862.1225
Classification Product Code
JFY  
Subsequent Product Code
CFR  
Date Received12/30/2019
Decision Date 05/10/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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