Cleared Traditional

E-Z Chek Chlorine Residual Test Strips (K100-0101B)

K222167 · Reprocessing Products Corporation (Rpc) · Gastroenterology & Urology
Oct 2022
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K222167 is an FDA 510(k) clearance for the E-Z Chek Chlorine Residual Test Strips (K100-0101B), a Strip, Test, Reagent, Residuals For Dialysate, Disinfectant (Class II — Special Controls, product code MSY), submitted by Reprocessing Products Corporation (Rpc) (Tucson, US). The FDA issued a Cleared decision on October 18, 2022, 89 days after receiving the submission on July 21, 2022. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5665.

Submission Details

510(k) Number K222167 FDA.gov
FDA Decision Cleared SESE
Date Received July 21, 2022
Decision Date October 18, 2022
Days to Decision 89 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code MSY — Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5665

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