Product Code: MSY FDA class 2 21 CFR 876.5665

Strip, Test, Reagent, Residuals For Dialysate, Disinfectant

Gastroenterology, Urology

A Reagent Test Strip for Disinfectant Residuals in Dialysate is a chemical test device used to detect and measure residual concentrations of dialysis disinfectants in dialysate fluid before treatment, ensuring patient safety by confirming disinfectant has been adequately rinsed from the dialysis system. It is FDA Class 2 with 510(k) requirements, product code MSY under 21 CFR 876.5665 in the Gastroenterology and Urology specialty, and carries a life-sustaining designation. The device is not an implant.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

Basic Information

Product Code: MSY
Device Class: FDA class 2
Regulation Number: 876.5665
Medical Specialty: Gastroenterology, Urology
Review Panel: GU
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✓

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 13 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K243898	Chlorine Sentinel II	Apr 11, 2025	Substantially Equivalent	Nelson Environmental Technologies, Inc.
K222167	E-Z Chek Chlorine Residual Test Strips (K100-0101B)	Oct 18, 2022	Substantially Equivalent	Reprocessing Products Corporation (Rpc)
K193169	Nelson Sentinel Series Basic Chlorine Sentinel	Oct 29, 2020	Substantially Equivalent	Nelson Environmental Technologies, Inc.
K132344	E-Z CHECK OZONE TEST STRIPS	Feb 25, 2014	Substantially Equivalent	Reprocessing Products Corporation (Rpc)
K090338	ULTRA LOW TOTAL CHLORINE, E-Z CHEK SENSITIVE TOTAL CHLORINE	May 08, 2009	Substantially Equivalent	Reprocessing Products Corp
K080712	SERIM HISENSE ULTRA 0.1, PART NUMBER 5167	May 06, 2008	Substantially Equivalent	Serim Research Corp.
K002011	GLUTARTEST 1 REAGENT STRIP	Jan 22, 2001	Substantially Equivalent	Integrated Biomedical Technology, Inc.
K001194	STERICHEK TOTAL CHLORINE REAGENT STRIPS	Jul 11, 2000	Substantially Equivalent	Environmental Test Systems, Inc.
K994226	STERICHEK TOTAL CHLORINE REAGENT STRIPS	Mar 22, 2000	Substantially Equivalent	Environmental Test Systems, Inc.
K983997	STERICHEK TOTAL CHLORINE TEST KIT	Apr 02, 1999	Substantially Equivalent	Environmental Test Systems, Inc.
K974064	MICRO X RESIDUAL TEST STRIPS	Dec 07, 1998	Substantially Equivalent	Reprocessing Products Corp
K980164	STERICHEK PERACETIC ACID REAGENT STRIPS	Apr 16, 1998	Substantially Equivalent	Environmental Test Systems, Inc.
K971598	STERICHEK CHLORINE REAGENT STRIPS	Jul 18, 1997	Substantially Equivalent	Environmental Test Systems, Inc.