STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS— 510(k) K003615

Name: FDA 510(k) clearance K003615
Creator: U.S. Food and Drug Administration
Published: 2001-02-01

Substantially Equivalent

Environmental Test Systems, Inc.

FDA 510(k) clearance K003615 for STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS, Substantially Equivalent on 2001-02-01. Applicant: Environmental Test Systems, Inc.. Device class: 2.

Clearance details

Applicant: Environmental Test Systems, Inc.
Product code: Code FKP
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 2000-11-22
Decision date: 2001-02-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Elkhart, IN, US

Download summary PDF View on FDA.gov ↗

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