# K062855: Calcium

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Nov 22, 2006 after 58 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: 2 generations back to K850281 (1985). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981578: CA, Abbott Laboratories (1998) Summary page 2.

## Most influential descendants
- K244042: Calcium2 (2025), 0 descendants of its own

## Indications for use
A calcium test system is a device intended to measure the total calcium level in serum, plasma, and urine. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

Source page: https://510kreport.com/device/K062855
Methodology: https://510kreport.com/methodology