# K994226: Sterichek Total Chlorine Reagent Strips

- Pathway: 510(k) (Traditional)
- Applicant: Environmental Test Systems, Inc.
- Decided: Mar 22, 2000 after 98 days
- Product code: MSY (Strip, Test, Reagent, Residuals For Dialysate, Disinfectant)
- Device class: 2
- Regulation: 21 CFR 876.5665
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Serim™ HiSense Test Kit: named in the summary without a submission number

## Indications for use
SteriChek™ Total Chlorine Reagent Strips provide a quick convenient means of testing for low levels of total chlorine (i.e. total chloramines and free chlorine) in water used to prepare dialysate.

Source page: https://510kreport.com/device/K994226
Methodology: https://510kreport.com/methodology