# K981794: Hichem Calcium Reagent Kit

- Pathway: 510(k) (Traditional)
- Applicant: Hichem Diagnostics
- Decided: Jul 29, 1998 after 69 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
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. The FDA summary names its predicate without a number.
- (no number) Beckman SYNCHRON Systems Calcium Reagent, product no. 442755: named in the summary without a submission number

## Indications for use
HiChem Calcium Reagent is intended for the quantitative determination of tatal calcium In serum, plasma and urine for the diagnosls and treatment of parathyroid disease, a variety of bone diseases, chronic renal diseasc and tetany (intermittent muscular contractions or spasms). This reagent is intended to be used in a professional setting or by trained personnel and Is not intended for home use.

Source page: https://510kreport.com/device/K981794
Methodology: https://510kreport.com/methodology