# K021334: Wiener Lab. CA-Color Arsenazo Iii AA, Model 4X50 ML Cat.NR. 1152004, Wiener Lab.CA-Color Arsenazo Iii AA, Model 8 X 20 5

- Pathway: 510(k) (Traditional)
- Applicant: Wiener Laboratories Saic
- Decided: Sep 10, 2002 after 137 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) WIENER LAB. CA-COLOR AA (Cat. No 1152002): named in the summary without a submission number

## Indications for use
The 'Wiener lab. Ca-Color Arsenazo Ill AA' test system is a quantitative in vitro diagnostic device intended to be used in the quantitative determination of calcium in human sera, heparinized plasmas and urine on both manual and automated systems. Measurements of calcium are used in the diagnosis and treatment of parathyroid diseases, a variety of bone diseases, chronic renal diseases and tetany (intermittent muscular contractions or spasms).

Source page: https://510kreport.com/device/K021334
Methodology: https://510kreport.com/methodology