# K012509: Phoenix Electrolyte Calibration Set for the Dade/Behring/Behring Dimension Chemistry System

- Pathway: 510(k) (Traditional)
- Applicant: Phoenix Diagnostics, Inc.
- Decided: Oct 9, 2001 after 64 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 K902675 (1990). 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)
- K902675: Multi Analyte Mixture, Calibrators, Phoenix Diagnostics, Inc. (1990)
- (no number) Alko Product A202-0: named in the summary without a submission number
- (no number) Alko Product A103-0: named in the summary without a submission number
- (no number) Alko Product A200-0: named in the summary without a submission number

## Indications for use
The pHoenix Electrolyte Calibrator Set is intended for use as calibrators to calibrate Na*, K™, CI" and TCO, for the Dade/Behring Dimension® Chemistry System with MultiPLY™ Integrated Multisensor module installed.

Source page: https://510kreport.com/device/K012509
Methodology: https://510kreport.com/methodology