Potassium Chloride Tablets
by Bionostics, Inc. 510(k)
Active
510(k) K840843
Overview
Potassium chloride tablets are solid dosage forms containing a defined amount of potassium chloride intended for use as a reference or calibration material in clinical chemistry testing of electrolyte and blood‑gas measurements. The tablets provide a stable source of potassium for instruments that measure blood‑gas parameters such as Pco₂, Po₂, and blood pH. They are classified as a Class II medical device under the FDA device name “Electrode Measurement, Blood‑Gases (Pco₂, Po₂) And Blood Ph.”
The product is cleared through FDA 510(k) submission K840843 with a traditional clearance type and is assigned product code CHL and regulation number 862.1120. It is supplied as individual tablets, each identified by the K‑number K840843, and is intended for single‑use in laboratory settings. The device is manufactured by Bionostics, Inc. and is regulated as a Class II device under the United States regulatory framework.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK840843 | Date17 Apr 1984 | 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- Withdrawn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
- CHL
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1120
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Other devices from Bionostics, Inc.
Questions
What is the intended use of the potassium chloride tablets?
The tablets serve as a reference or calibration material for clinical chemistry instruments that measure electrolytes and blood‑gas parameters such as Pco₂, Po₂, and pH. By providing a known amount of potassium chloride, they help ensure accurate instrument performance and reliable test results.
How are the tablets supplied and are they sterile?
Each tablet is supplied individually and identified by the K‑number K840843. They are intended for single‑use in laboratory settings. The device description does not specify sterility, so they should be handled according to the laboratory’s standard aseptic procedures for calibration materials.
Can the tablets be reused for multiple calibrations?
No. The product is designated for single‑use only. Reusing a tablet could compromise its defined potassium content and affect the accuracy of subsequent calibrations, which is why each measurement should use a fresh tablet.
What regulatory pathway does this device follow?
The potassium chloride tablets were cleared through an FDA 510(k) submission (K840843) with a traditional clearance type. They are classified as a Class II medical device under the FDA device name “Electrode Measurement, Blood‑Gases (Pco₂, Po₂) And Blood Ph.”
Are there any size or model variations of this product?
The data list only a single product identified by the K‑number K840843. No additional sizes, strengths, or model numbers are mentioned, indicating that the offering consists of a uniform tablet format for calibration purposes.