# K090283: Calibrator 1,2, and 3 Models: Gen-CAL1, Gen-CAL2, and Gen-CAL3

- Pathway: 510(k) (Abbreviated)
- Applicant: Genchem, Inc.
- Decided: Jun 5, 2009 after 120 days
- Product code: JIX (Calibrator, Multi-Analyte Mixture)
- Device class: 2
- Regulation: 21 CFR 862.1150
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
SYNCHRON® CX Multi-Analyte Mixture Calibrators 1, 2, and 3 are intended to calibrate the Beckman® SYNCHRON CX® Systems for quantitative determination of sodium, potassium, chloride, urea, glucose, creatinine, calcium, and total CO 2

Source page: https://510kreport.com/device/K090283
Methodology: https://510kreport.com/methodology