Medical Device Manufacturer · US , Elkhart , IN

Environmental Test Systems, Inc.

8 submissions · 8 cleared · Since 1997
8
Total
8
Cleared
0
Denied

Environmental Test Systems, Inc. — FDA 510(k) Submissions

Environmental Test Systems, Inc. has submitted 8 FDA 510(k) premarket notifications since 1997, of which 8 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Strip, Test, Reagent, Residuals For Dialysate, Disinfectant, System, Dialysate Delivery, Single Patient, Strip, Dialysate Ph Indicator, Dialyzer Reprocessing System . Use the specialty filter in the sidebar to narrow results.

8 devices
1–8 of 8
STERICHEK BICARB PH REAGENT STRIPS
K031267 · MNV Strip, Dialysate Ph... · Gastroenterology & Urology
Dec 2003 246d
STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS
K003615 · FKP System, Dialysate... · Gastroenterology & Urology
Feb 2001 71d
STERICHEK TOTAL CHLORINE REAGENT STRIPS
K001194 · MSY Strip, Test, Reagent,... · Gastroenterology & Urology
Jul 2000 90d
STERICHEK TOTAL CHLORINE REAGENT STRIPS
K994226 · MSY Strip, Test, Reagent,... · Gastroenterology & Urology
Mar 2000 98d
STERICHEK TOTAL CHLORINE TEST KIT
K983997 · MSY Strip, Test, Reagent,... · Gastroenterology & Urology
Apr 1999 143d
STERICHEK PERACETIC ACID REAGENT STRIPS
K980164 · MSY Strip, Test, Reagent,... · Gastroenterology & Urology
Apr 1998 90d
STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS
K974798 · LIF Dialyzer Reprocessing System · Gastroenterology & Urology
Mar 1998 88d
STERICHEK CHLORINE REAGENT STRIPS
K971598 · MSY Strip, Test, Reagent,... · Gastroenterology & Urology
Jul 1997 78d
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