Corning Calcium Ph Analyzer 634

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K844188 ↗

FDA Product Code

JFP

Device Class

Class II

Regulation

21 CFR Part 862.1145

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

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• What is the Corning Calcium Ph Analyzer 634 used for?

  The Corning Calcium Ph Analyzer 634 is used in clinical chemistry for the measurement of ionized calcium in blood samples. It functions as an electrode, ion specific, calcium device, enabling accurate assessment of calcium levels critical for diagnosing metabolic and parathyroid disorders.

• How is the Corning Calcium Ph Analyzer 634 supplied and is it reusable?

  The device is supplied as a standalone electrode sensor designed for use with compatible analyzers. It is intended for repeated use in clinical laboratory settings when properly maintained and calibrated, as it is not designated as single-use in the provided data.

• What regulatory pathway was used for the Corning Calcium Ph Analyzer 634?

  The Corning Calcium Ph Analyzer 634 received clearance through the FDA 510(k) process as a substantially equivalent device. This traditional 510(k) submission was based on demonstrating equivalence to a legally marketed predicate device under product code JFP and regulation number 862.1145.