Calcium (Arsenazo III) Reagent
by Sigma Diagnostics, Inc. 510(k)
Active
510(k) K894204
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK894204 | Date4 Oct 1989 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- CJY
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1145
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
This device is a calcium-sensitive metallochromic dye reagent used for the spectrophotometric determination of calcium in biological samples. It functions as a color-forming reagent in clinical chemistry applications.
The reagent is supplied as a powder or solution for in vitro diagnostic use. It is a single-use reagent intended for laboratory testing and has received FDA 510(k) clearance under product code CJY for clinical chemistry.
Other devices from Sigma Diagnostics, Inc.
Questions
AI-generated answers, 22 Sep 2026
What is the Calcium Arsenazo III Reagent used for?
It is used as a color-forming reagent in the spectrophotometric determination of calcium in biological samples, enabling quantitative measurement in clinical chemistry laboratory testing.
How is the Calcium Arsenazo III Reagent supplied and is it single-use?
The reagent is supplied as either a powder or a solution for in vitro diagnostic use and is designated as a single-use reagent, meaning it is intended for one-time application in laboratory testing procedures.
What regulatory clearance does the Calcium Arsenazo III Reagent have?
The device has received FDA 510(k) clearance under product code CJY for clinical chemistry, indicating it was found substantially equivalent to a legally marketed predicate device.