# K040972: Calcium, Azo Dye Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Genchem, Inc.
- Decided: Dec 27, 2004 after 257 days
- Product code: CJY (Azo Dye, Calcium)
- Device class: 2
- Regulation: 21 CFR 862.1145
- 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 K941764 (1994). 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)
- K941764: Hichem Calcium Reagent for the Synchron CX3 Prod. NO. 88808, Hi Chem, Inc. (1994) Summary page 1.

## Indications for use
GenChem Calcium Reagent is intended for the quantitative determination of total calcium in serum, plasma and urine on the Beckman SYNCHRON CX3® System to aid in the diagnosis of diseases associated with hypercalcemia and hypocalcemia.

Source page: https://510kreport.com/device/K040972
Methodology: https://510kreport.com/methodology