Vision Potassium
by Abbott Laboratories 510(k)
Active
510(k) K850950
Overview
Vision Potassium is an ion-specific potassium electrode used in clinical chemistry to measure potassium levels in biological samples. It operates as a Class 2 medical device designed for integration into analytical chemistry systems to provide quantitative potassium concentration data.
The device is supplied by Abbott Laboratories and is intended for use in clinical laboratory settings under the supervision of trained personnel. It is regulated under FDA product code CEM and was cleared through the Traditional 510(k) pathway. The device is listed as single-use or component-based depending on system configuration, and specific storage conditions, sterility claims, and MRI safety profiles are not detailed in the available specifications.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK850950 | Date12 Aug 1985 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- CEM
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1600
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Abbott Laboratories
Questions
What is the Vision Potassium device used for?
The Vision Potassium is an ion-specific electrode designed for clinical chemistry. It is used to measure potassium levels in biological samples, providing quantitative concentration data for laboratory analysis.
Who supplies the Vision Potassium electrode?
The device is supplied by Abbott Laboratories, a manufacturer based in Abbott Park, Illinois, United States. It is intended for use in clinical laboratory settings under the supervision of trained personnel.
Is the Vision Potassium device single-use or reusable?
The device is listed as single-use or component-based, depending on the system configuration. Specific reuse instructions or sterilization claims are not detailed in the available specifications.
What regulatory pathway did the Vision Potassium follow?
The device was cleared through the FDA Traditional 510(k) pathway under product code CEM. It was determined to be substantially equivalent to existing devices, with a decision date of August 12, 1985.
Are there any storage or safety specifications available?
Specific storage conditions, sterility claims, and MRI safety profiles are not detailed in the available specifications for the Vision Potassium device. Users should refer to the manufacturer's labeling for detailed handling instructions.