STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS— 510(k) K974798

Name: FDA 510(k) clearance K974798
Creator: U.S. Food and Drug Administration
Published: 1998-03-20

Substantially Equivalent

Environmental Test Systems, Inc.

FDA 510(k) clearance K974798 for STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS, Substantially Equivalent on 1998-03-20. Applicant: Environmental Test Systems, Inc.. Device class: 2.

Clearance details

Applicant: Environmental Test Systems, Inc.
Product code: Code LIF
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 1997-12-22
Decision date: 1998-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkhart, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LIF

view all

K091360 — CLEARFLUX DIALYZER REPROCESSING SYSTEM2010-11-03
K043126 — ASSIST HEADER CLEANER2005-02-03
K040660 — STERICHEK GLUTARALDEHYDE REAGENT STRIPS2004-11-15
K033505 — RENACLEAN SH DIALYZER CLEANING SYSTEM2004-04-27
K024076 — MAKY 21.1 DIALYZER REPROCESSING SYSTEM2003-09-26

More clearances from Environmental Test Systems, Inc.

view all

K031267 — STERICHEK BICARB PH REAGENT STRIPS2003-12-23
K003615 — STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS2001-02-01
K001194 — STERICHEK TOTAL CHLORINE REAGENT STRIPS2000-07-11
K994226 — STERICHEK TOTAL CHLORINE REAGENT STRIPS2000-03-22
K983997 — STERICHEK TOTAL CHLORINE TEST KIT1999-04-02

Data sourced from openFDA. This site is unofficial and independent of the FDA.