Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

NIKKICART

K-Number: K221652 · 2023-03-03

ApplicantRenal Care Dialysis Solutions, S.A. DE C.V.
Decision Date2023-03-03
Product CodeKPO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

NIKKICART is a medical device manufactured by Renal Care Dialysis Solutions, S.A. DE C.V.. It received FDA 510(k) clearance on 2023-03-03 under approval number K221652. The device is classified under product code KPO. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NIKKICART?

NIKKICART is a medical device that received FDA 510(k) clearance on 2023-03-03. It is manufactured by Renal Care Dialysis Solutions, S.A. DE C.V.. The 510(k) number is K221652.

When was NIKKICART approved by the FDA?

NIKKICART received FDA 510(k) clearance on 2023-03-03, under approval number K221652.

What company makes NIKKICART?

NIKKICART is manufactured by Renal Care Dialysis Solutions, S.A. DE C.V..

What is the FDA product code for NIKKICART?

The FDA product code for NIKKICART is KPO.

Related Devices (Code: KPO)

K160847Rockwell Medical CitraPure Acid ConcetrateRockwell Medical K171015CitryteDi-Chem, Inc. K162716bibagFresenius Medical Care Renal Therapies Group, LLC K162887PrismaSATEBaxter Healthcare Corporation K180679CitriCon Liquid and Powder (Acid Concentrate acidified with Citric Acid), AcetiCon Liquid and Powder (Acid Concentrate acidified with Acetic Acid or Na Di Acetate), BicarboCon Liquid and Powder (Bicarb Concentrate), RenaCon Liquid and Powder (Acetate Concentrate with Na Acetate)Global Scientific Technologies, LLC K171750Citric Complete Dry Citric Acid (45X)Dimesol USA, LLC

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.

↑