# K101750: RPC E-Z Chek 6.8-8.5 PH Test Strips, Model K100-0117 and E-Z Chek 0-14 PH Test Strips, Model K100-0104

- Pathway: 510(k) (Traditional)
- Applicant: Reprocessing Products Corp
- Decided: Jan 7, 2011 after 199 days
- Product code: MNV (Strip, Dialysate Ph Indicator)
- 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®S Blcarb PH Reagent Strips: named in the summary without a submission number

## Indications for use
The Reprocessing Product Corporation (RPC) pH Test Strips are indicated for determining the pH of acid dialysates, bicarbonate dialysates, or water. These Test Strips are indicated for testing acid/bicarbonate dialysates and water. * pH Test Strips are comprised of two different pH ranges: * pH = 6.8-8.5 (K100-0l 17) is for acid/bicarbonate dialysate, bicarbonate concentrate and water * pH = 0-14 (K 100-0 104) is for water used to make up dialysate.

Source page: https://510kreport.com/device/K101750
Methodology: https://510kreport.com/methodology