# K860418: Creatinine Reagent Set

- Pathway: 510(k) (Traditional)
- Applicant: Sterling Diagnostics, Inc.
- Decided: Feb 11, 1986 after 7 days
- Product code: CGX (Alkaline Picrate, Colorimetry, Creatinine)
- Device class: 2
- Regulation: 21 CFR 862.1225
- 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. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Jul 20, 2016 · Class III · Z-0931-2017: Sterling Diagnostics, Inc. initiated a recall on 7/20/2016 for multiple diagnostic kits due to a recision of the previously extended expiration dates for the kits.

Source page: https://510kreport.com/device/K860418
Methodology: https://510kreport.com/methodology