# K042551: Multi-Chem Calibrator a

- Pathway: 510(k) (Traditional)
- Applicant: Wako Chemicals USA, Inc.
- Decided: Nov 16, 2004 after 57 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
The Multi-Chem Calibrator A is designed to be used with Wako's assays to determine the points of reference that are used in the determination of Calcium, FE, UIBC, Inorganic Phosphorus and Magnesium in human serum.

Source page: https://510kreport.com/device/K042551
Methodology: https://510kreport.com/methodology