Ph 6.838 Ref. Buffer

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K831019 ↗

FDA Product Code

CHL

Device Class

Class II

Regulation

21 CFR Part 862.1120

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• What is the PH 6.838 Reference Buffer used for?

  The PH 6.838 Reference Buffer is a standardized liquid reagent designed specifically for calibrating and verifying the accuracy of pH meters and blood gas analyzers. It ensures precise measurement of pH levels, particularly for electrodes used in clinical chemistry to analyze blood gases (such as PCO₂, PO₂) and pH. This calibration step is critical for maintaining reliable diagnostic results in laboratory settings.

• How is the PH 6.838 Reference Buffer supplied, and is it reusable?

  The PH 6.838 Reference Buffer is supplied as a liquid reagent in a format intended exclusively for single-use calibration procedures. It is not designed for reuse, as single-use calibration solutions provide consistent accuracy without the risk of contamination or degradation from repeated exposure.

• Is the PH 6.838 Reference Buffer sterile, and can it be used in MRI environments?

  The PH 6.838 Reference Buffer does not specify sterility or MRI safety information in its documentation. It is intended for laboratory use in calibrating equipment, not for direct patient contact or use in MRI environments. Always verify compatibility with your specific equipment and facility protocols.

• What regulatory clearance does the PH 6.838 Reference Buffer hold?

  The PH 6.838 Reference Buffer holds FDA clearance under the 510(k) submission K831019, classified under regulation 862.1120 as an Electrode Measurement device for Clinical Chemistry. This clearance confirms its substantial equivalence to a predicate device and its compliance with U.S. regulatory standards for clinical chemistry applications.

• Are there different sizes or models of the PH 6.838 Reference Buffer?

  The PH 6.838 Reference Buffer is identified by its specific pH value (6.838) and reference designation, indicating a standardized formulation. While the device data does not list multiple sizes or models, it is supplied as a single standardized liquid reagent. For specific packaging details, refer to the manufacturer’s product documentation or contact Fisher Scientific Co., LLC.