Medical Device Manufacturer · US , Elkhart , IN

Environmental Test Systems, Inc. - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 1997

Recent clearances: STERICHEK TOTAL CHLORINE REAGENT STRIPS, STERICHEK TOTAL CHLORINE REAGENT STRIPS, STERICHEK TOTAL CHLORINE TEST KIT

8

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - Environmental Test Systems, Inc. Gastroenterology & Urology ✕

8 devices

1-8 of 8

Cleared Dec 23, 2003

STERICHEK BICARB PH REAGENT STRIPS

Gastroenterology & Urology · 246d

Cleared Feb 01, 2001

STERICHEK SENSITIVE-FEED WATER AND RINSE WATER REAGENT STRIPS

Gastroenterology & Urology · 71d

Cleared Jul 11, 2000

STERICHEK TOTAL CHLORINE REAGENT STRIPS

Gastroenterology & Urology · 90d

Cleared Mar 22, 2000

STERICHEK TOTAL CHLORINE REAGENT STRIPS

Gastroenterology & Urology · 98d

Cleared Apr 02, 1999

STERICHEK TOTAL CHLORINE TEST KIT

Gastroenterology & Urology · 143d

Cleared Apr 16, 1998

STERICHEK PERACETIC ACID REAGENT STRIPS

Gastroenterology & Urology · 90d

Cleared Mar 20, 1998

STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS

Gastroenterology & Urology · 88d

Cleared Jul 18, 1997

STERICHEK CHLORINE REAGENT STRIPS

Gastroenterology & Urology · 78d