Cleared Traditional

STERICHEK TOTAL CHLORINE REAGENT STRIPS

K001194 · Environmental Test Systems, Inc. · Gastroenterology & Urology
Jul 2000
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K001194 is an FDA 510(k) clearance for the STERICHEK TOTAL CHLORINE REAGENT STRIPS, a Strip, Test, Reagent, Residuals For Dialysate, Disinfectant (Class II — Special Controls, product code MSY), submitted by Environmental Test Systems, Inc. (Elkhart, US). The FDA issued a Cleared decision on July 11, 2000, 90 days after receiving the submission on April 12, 2000. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5665.

Submission Details

510(k) Number K001194 FDA.gov
FDA Decision Cleared SESE
Date Received April 12, 2000
Decision Date July 11, 2000
Days to Decision 90 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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