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FDA 510(k)

Citric Complete Liquid Citric Acid Concentrate

K-Number: K223431 · 2023-08-04

ApplicantNipro Renal Solutions USA, Corp.
Decision Date2023-08-04
Product CodeKPO
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Citric Complete Liquid Citric Acid Concentrate is a medical device manufactured by Nipro Renal Solutions USA, Corp.. It received FDA 510(k) clearance on 2023-08-04 under approval number K223431. 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 Citric Complete Liquid Citric Acid Concentrate?

Citric Complete Liquid Citric Acid Concentrate is a medical device that received FDA 510(k) clearance on 2023-08-04. It is manufactured by Nipro Renal Solutions USA, Corp.. The 510(k) number is K223431.

When was Citric Complete Liquid Citric Acid Concentrate approved by the FDA?

Citric Complete Liquid Citric Acid Concentrate received FDA 510(k) clearance on 2023-08-04, under approval number K223431.

What company makes Citric Complete Liquid Citric Acid Concentrate?

Citric Complete Liquid Citric Acid Concentrate is manufactured by Nipro Renal Solutions USA, Corp..

What is the FDA product code for Citric Complete Liquid Citric Acid Concentrate?

The FDA product code for Citric Complete Liquid Citric Acid Concentrate is KPO.

Related Clinical Trials

NCT07531901 Evaluating the Feasibility and Reliability of Using Handheld Nebulizers to Conduct Cough Sensitivity Testing With Citric Acid NOT_YET_RECRUITING NCT04248582 Cryotherapy for Locally Advanced Esophageal Cancer ACTIVE_NOT_RECRUITING NCT06388993 Marrow Cellution™ vs. Traditional BMA Harvest Project RECRUITING

Other Devices by Nipro Renal Solutions USA, Corp.

K193155Nipro Dry Complete Dry Acid Concentrate for Hemodialysis

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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