Yumizen C1200 CRP
K-Number: K191993 · 2019-10-03
ApplicantHORIBA ABX SAS
Decision Date2019-10-03
Product CodeDCK
Advisory CommitteeIM
DecisionSubstantially Equivalent
Device Summary
Yumizen C1200 CRP is a medical device manufactured by HORIBA ABX SAS. It received FDA 510(k) clearance on 2019-10-03 under approval number K191993. The device is classified under product code DCK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Yumizen C1200 CRP?
Yumizen C1200 CRP is a medical device that received FDA 510(k) clearance on 2019-10-03. It is manufactured by HORIBA ABX SAS. The 510(k) number is K191993.
When was Yumizen C1200 CRP approved by the FDA?
Yumizen C1200 CRP received FDA 510(k) clearance on 2019-10-03, under approval number K191993.
What company makes Yumizen C1200 CRP?
Yumizen C1200 CRP is manufactured by HORIBA ABX SAS.
What is the FDA product code for Yumizen C1200 CRP?
The FDA product code for Yumizen C1200 CRP is DCK.
Other Devices by HORIBA ABX SAS
K170353ABX MICROS ES 60 OT and ABX MICROS ES 60 CT
K191245Yumizen C1200 ALP, Yumizen C1200 Albumin
K191396Yumizen C1200 Calcium AS, Yumizen C1200 Creatinine Jaffe
K193525Yumizen C1200 Immunoglobulin A, Yumizen C1200 Immunoglobulin G, Yumizen C1200 Immunoglobulin M
K192028Yumizen C1200 CRP
K191562Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor
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K192028Yumizen C1200 CRPHORIBA ABX SAS
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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.