Cleared Traditional

HemoCare Bicarbonate Concentrate Set (BCS)

K240920 · Deka Research and Development · Gastroenterology & Urology
Jul 2024
Decision
99d
Days
Class 2
Risk

About This 510(k) Submission

K240920 is an FDA 510(k) clearance for the HemoCare Bicarbonate Concentrate Set (BCS), a Dialysate Concentrate For Hemodialysis (liquid Or Powder) (Class II — Special Controls, product code KPO), submitted by Deka Research and Development (Manchester, US). The FDA issued a Cleared decision on July 12, 2024, 99 days after receiving the submission on April 4, 2024. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5820.

Submission Details

510(k) Number K240920 FDA.gov
FDA Decision Cleared SESE
Date Received April 04, 2024
Decision Date July 12, 2024
Days to Decision 99 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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