Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe
K-Number: K191396 · 2019-07-26
ApplicantHORIBA ABX SAS
Decision Date2019-07-26
Product CodeCJY
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe is a medical device manufactured by HORIBA ABX SAS. It received FDA 510(k) clearance on 2019-07-26 under approval number K191396. The device is classified under product code CJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe?
Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe is a medical device that received FDA 510(k) clearance on 2019-07-26. It is manufactured by HORIBA ABX SAS. The 510(k) number is K191396.
When was Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe approved by the FDA?
Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe received FDA 510(k) clearance on 2019-07-26, under approval number K191396.
What company makes Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe?
Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe is manufactured by HORIBA ABX SAS.
What is the FDA product code for Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe?
The FDA product code for Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe is CJY.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.