# K953854: Watercheck Reagent Strip for Chlorine & Peroxide

- Pathway: 510(k) (Traditional)
- Applicant: Integrated Biomedical Technology, Inc.
- Decided: Mar 11, 1996 after 217 days
- Product code: FKP (System, Dialysate Delivery, Single Patient)
- Device class: 2
- Regulation: 21 CFR 876.5820
- 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 Residual Chlorine Strip: named in the summary without a submission number
- (no number) Renalin Residual Test Strips: named in the summary without a submission number

## Indications for use
WaterCheck™ CP Reagent Strip is intended to be used in detecting residual chlorine or peroxide in dialysis water. It also is used for detection of effective high level of chlorine in the disinfecting solution.

Source page: https://510kreport.com/device/K953854
Methodology: https://510kreport.com/methodology