FDA.reportPublic FDA data

510(k) K243898

Device
Chlorine Sentinel II
Applicant
Nelson Environmental Technologies, Inc.
510(k) number
K243898
Product code
MSY
Decision
Substantially Equivalent (SESE)
Decision date
2025-04-11
Date received
2024-12-19
Regulation
876.5665
Classification name
Strip, Test, Reagent, Residuals For Dialysate, Disinfectant
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
QuocHuy (Huy) Nguyen
Address
813 E Fir Ave. Mcallen TX US 78501 78501

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MSY#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K222167E-Z Chek Chlorine Residual Test Strips (K100-0101B)Reprocessing Products Corporation (Rpc)2022-10-18
K193169Nelson Sentinel Series Basic Chlorine SentinelNelson Environmental Technologies, Inc.2020-10-29
K132344E-Z CHECK OZONE TEST STRIPSReprocessing Products Corporation (Rpc)2014-02-25
K090338ULTRA LOW TOTAL CHLORINE, E-Z CHEK SENSITIVE TOTAL CHLORINEReprocessing Products Corp2009-05-08
K080712SERIM HISENSE ULTRA 0.1, PART NUMBER 5167Serim Research Corp.2008-05-06
K002011GLUTARTEST 1 REAGENT STRIPIntegrated Biomedical Technology, Inc.2001-01-22
K001194STERICHEK TOTAL CHLORINE REAGENT STRIPSEnvironmental Test Systems, Inc.2000-07-11
K994226STERICHEK TOTAL CHLORINE REAGENT STRIPSEnvironmental Test Systems, Inc.2000-03-22
K983997STERICHEK TOTAL CHLORINE TEST KITEnvironmental Test Systems, Inc.1999-04-02
K974064MICRO X RESIDUAL TEST STRIPSReprocessing Products Corp1998-12-07
K980164STERICHEK PERACETIC ACID REAGENT STRIPSEnvironmental Test Systems, Inc.1998-04-16
K971598STERICHEK CHLORINE REAGENT STRIPSEnvironmental Test Systems, Inc.1997-07-18