K-number	K191396
Device name	Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe
Applicant	HORIBA ABX SAS
Product code	CJY
Device class	Class II
Decision date	Jul 26, 2019
Decision	Substantially Equivalent
Regulation	862.1145

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Source

View the full FDA submission: accessdata.fda.gov

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Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe

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