PH Calibration Buffers
510(k) K772106
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK772106 | Date6 Dec 1977 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JIT
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1150
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 26 Sep 2026
PH Calibration Buffers are reference solutions of known pH values used for the calibration of sensors to achieve accurate pH readings. These solutions are essential for routine pH meter calibration to capture the accurate pH range of acids or bases.
These ready-to-use prepared solutions are supplied to eliminate the time, expense, and contamination risks associated with mixing buffers. The device is authorized under FDA 510k clearance.
Other devices from General Diagnostics
Questions
AI-generated answers, 26 Sep 2026
What is the purpose of these pH Calibration Buffers?
These buffers are reference solutions with known pH values used to calibrate pH sensors. Calibration is necessary to ensure that pH meters provide accurate readings when measuring the acidity or alkalinity of a substance.
How are these buffers supplied for clinical use?
The buffers are supplied as ready-to-use prepared solutions. This format is intended to save time and reduce the expense and potential contamination risks that are typically associated with manually mixing buffer solutions in a laboratory or clinical setting.
What is the regulatory status of this device?
This device is authorized under FDA 510k clearance. It is classified as a calibrator under the clinical chemistry specialty, as indicated by its regulatory filing.