# K012987: Phoenix Electrolyte Calibration Set for the Medical Easylyte Calcium Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Phoenix Diagnostics, Inc.
- Decided: Nov 7, 2001 after 62 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
Longest line of descent: 1 generation back to K943091 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K943091: Easy Lyte Calcium Analyzer, Medica Corp. (1995) Summary page 3.

## Indications for use
The pHoenix Electrolyte Calibrator Set for the Medica EasyLyte Calcium Analyzer is intended for use as calibrators to calibrate Na*, K*, Ca* and pH for the Medica EasyLyte Calcium Analyzer.

Source page: https://510kreport.com/device/K012987
Methodology: https://510kreport.com/methodology