# K123805: E-Z Chek Blood Leak Test Strips

- Pathway: 510(k) (Traditional)
- Applicant: Reprocessing Products Corp
- Decided: Mar 20, 2013 after 99 days
- Product code: FJD (Detector, Leak, Blood)
- 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) Serimc Blood Leak Test Strips: named in the summary without a submission number

## Indications for use
The Reprocessing Product Corporation (RPC) E-Z Chek® Blood Leak Test Strips are indicated for detecting the presence or absence of blood in dialysate during hemodialysis treatments.

Source page: https://510kreport.com/device/K123805
Methodology: https://510kreport.com/methodology