Dma Calcium Plus Procedure
by Data Medical Associates, Inc. 510(k)
Active
510(k) K944255
Overview
The DMA Calcium Plus Procedure is a clinical chemistry device used for calcium testing. It is classified as an Azo Dye device and is intended for laboratory use in measuring calcium levels.
The device is supplied by Data Medical Associates, Inc. and is FDA 510(k) cleared with product code CJY. It is a class II device that received clearance on December 6, 1994, and is not indicated as single-use or reusable.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK944255 | Date6 Dec 1994 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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
Other devices from Data Medical Associates, Inc.
Questions
What is the DMA Calcium Plus Procedure used for?
The DMA Calcium Plus Procedure is a clinical chemistry device specifically designed for laboratory use in measuring calcium levels in patient samples. It is classified as an Azo Dye device and is intended for professional laboratory settings.
Is the DMA Calcium Plus Procedure single-use or reusable?
The device is not indicated as single-use or reusable in the provided information. This suggests it may be designed for multiple uses under appropriate laboratory conditions, though specific reprocessing instructions would need to be referenced from the manufacturer's documentation.
What regulatory status does the DMA Calcium Plus Procedure have?
The DMA Calcium Plus Procedure is FDA 510(k) cleared with product code CJY. It is classified as a class II device that received clearance on December 6, 1994, and is substantially equivalent to other marketed devices in this category.
How is the DMA Calcium Plus Procedure supplied?
The device is supplied by Data Medical Associates, Inc. The specific packaging, components, and quantities per package are not detailed in the provided information, so these details would need to be obtained directly from the manufacturer.