MSY · Class II · 21 CFR 876.5665

FDA Product Code MSY: Strip, Test, Reagent, Residuals For Dialysate, Disinfectant

Leading manufacturers include Environmental Test Systems, Inc., Reprocessing Products Corp and Reprocessing Products Corporation (Rpc).

13
Total
13
Cleared
155d
Avg days
1997
Since
Stable submission activity - 1 submissions in the last 2 years
Review times improving: avg 113d recently vs 158d historically

FDA 510(k) Cleared Strip, Test, Reagent, Residuals For Dialysate, Disinfectant Devices (Product Code MSY)

13 devices
1–13 of 13
Cleared Apr 11, 2025
Chlorine Sentinel II
K243898
Nelson Environmental Technologies, Inc.
Gastroenterology & Urology · 113d
Cleared Oct 18, 2022
E-Z Chek Chlorine Residual Test Strips (K100-0101B)
K222167
Reprocessing Products Corporation (Rpc)
Gastroenterology & Urology · 89d
Cleared Oct 29, 2020
Nelson Sentinel Series Basic Chlorine Sentinel
K193169
Nelson Environmental Technologies, Inc.
Gastroenterology & Urology · 349d
Cleared Feb 25, 2014
E-Z CHECK OZONE TEST STRIPS
K132344
Reprocessing Products Corporation (Rpc)
Gastroenterology & Urology · 211d
Cleared May 08, 2009
ULTRA LOW TOTAL CHLORINE, E-Z CHEK SENSITIVE TOTAL CHLORINE
K090338
Reprocessing Products Corp
Gastroenterology & Urology · 87d
Cleared May 06, 2008
SERIM HISENSE ULTRA 0.1, PART NUMBER 5167
K080712
Serim Research Corp.
Gastroenterology & Urology · 54d
Cleared Jan 22, 2001
GLUTARTEST 1 REAGENT STRIP
K002011
Integrated Biomedical Technology, Inc.
Gastroenterology & Urology · 203d
Cleared Jul 11, 2000
STERICHEK TOTAL CHLORINE REAGENT STRIPS
K001194
Environmental Test Systems, Inc.
Gastroenterology & Urology · 90d
Cleared Mar 22, 2000
STERICHEK TOTAL CHLORINE REAGENT STRIPS
K994226
Environmental Test Systems, Inc.
Gastroenterology & Urology · 98d
Cleared Apr 02, 1999
STERICHEK TOTAL CHLORINE TEST KIT
K983997
Environmental Test Systems, Inc.
Gastroenterology & Urology · 143d
Cleared Dec 07, 1998
MICRO X RESIDUAL TEST STRIPS
K974064
Reprocessing Products Corp
Gastroenterology & Urology · 406d
Cleared Apr 16, 1998
STERICHEK PERACETIC ACID REAGENT STRIPS
K980164
Environmental Test Systems, Inc.
Gastroenterology & Urology · 90d
Cleared Jul 18, 1997
STERICHEK CHLORINE REAGENT STRIPS
K971598
Environmental Test Systems, Inc.
Gastroenterology & Urology · 78d

About Product Code MSY - Regulatory Context

510(k) Submission Activity

13 total 510(k) submissions under product code MSY since 1997, with 13 receiving FDA clearance (average review time: 155 days).

Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.

FDA 510(k) Review Time - MSY Product Code

Recent submissions under MSY have taken an average of 113 days to reach a decision - down from 158 days historically, suggesting improved FDA processing for this classification.

MSY devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →