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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name azo dye, calcium
510(k) Number K191396
Device Name Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe
Applicant
Horiba ABX SAS
Parc Euromedecine, Rue du Caducee – BP7290
Montpellier Cedex 4,  FR 341184
Applicant Contact Caroline Ferrer
Correspondent
Horiba ABX SAS
Parc Euromedecine, Rue du Caducee – BP7290
Montpellier Cedex 4,  FR 341184
Correspondent Contact Caroline Ferrer
Regulation Number862.1145
Classification Product Code
CJY  
Subsequent Product Code
CGX  
Date Received05/24/2019
Decision Date 07/26/2019
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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