# K974798: Sterichek (TM) Residual Peroxide Reagent Strps

- Pathway: 510(k) (Traditional)
- Applicant: Environmental Test Systems, Inc.
- Decided: Mar 20, 1998 after 88 days
- Product code: LIF (Dialyzer Reprocessing System)
- Device class: 2
- Regulation: 21 CFR 876.5820
- Recalls of this device: 1 (0 Class I)
- 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™ Peroxide Reagent Strips: named in the summary without a submission number

## Recalls of this device
- Apr 21, 2009 · Not classified · Z-2016-2009: Some of the reagent strip bottles contain the incorrect strips

## Indications for use
SteriChek™ Residual Peroxide Reagent Strips provide a convenient means for measuring the concentration of peroxide remaining in water being used to rinse out dialysate lines and dialyzers following disinfection with peroxide/peracetic acid.

Source page: https://510kreport.com/device/K974798
Methodology: https://510kreport.com/methodology