Cleared Traditional

Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate

K212620 · Fresenius Medical Care Renal Therapies Group, LLC · Gastroenterology & Urology
May 2022
Decision
267d
Days
Class 2
Risk

About This 510(k) Submission

K212620 is an FDA 510(k) clearance for the Citrasate Liquid Acid Concentrate, NaturaLyte Liquid Acid Concentrate, a Dialysate Concentrate For Hemodialysis (liquid Or Powder) (Class II — Special Controls, product code KPO), submitted by Fresenius Medical Care Renal Therapies Group, LLC (Waltham, US). The FDA issued a Cleared decision on May 12, 2022, 267 days after receiving the submission on August 18, 2021. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.

Submission Details

510(k) Number K212620 FDA.gov
FDA Decision Cleared SESE
Date Received August 18, 2021
Decision Date May 12, 2022
Days to Decision 267 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code KPO — Dialysate Concentrate For Hemodialysis (liquid Or Powder)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5820

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