STERICHEK TOTAL CHLORINE REAGENT STRIPS— 510(k) K001194

Name: FDA 510(k) clearance K001194
Creator: U.S. Food and Drug Administration
Published: 2000-07-11

Substantially Equivalent

Environmental Test Systems, Inc.

FDA 510(k) clearance K001194 for STERICHEK TOTAL CHLORINE REAGENT STRIPS, Substantially Equivalent on 2000-07-11. Applicant: Environmental Test Systems, Inc.. Device class: 2.

Clearance details

Applicant: Environmental Test Systems, Inc.
Product code: Code MSY
Device class: Class 2
Regulation: 21 CFR 876.5665
Advisory panel: Gastroenterology, Urology
Date received: 2000-04-12
Decision date: 2000-07-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkhart, IN, US

Download summary PDF View on FDA.gov ↗

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