Miniature Ion Selective Electrodes

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K802856 ↗

FDA Product Code

JFP

Device Class

Class II

Regulation

21 CFR Part 862.1145

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Modified Sodium Electrode

  Class II

  FDA 510(k) K863907 Active Cleared 10 Dec 1986

• Electrolyte Analyzer

  Class II

  FDA 510(k) K851808 Active Cleared 25 Jun 1985

• Calcium and Ph Electrolyte Analyzer

  Class II

  FDA 510(k) K895397 Active Cleared 12 Dec 1989

• Model 400/450 Electrolyte Analyzer

  Class II

  FDA 510(k) K932179 Active Cleared 17 Nov 1993

• Potassium and Sodium Electrolyte Analyzer

  Class II

  FDA 510(k) K890792 Active Cleared 3 May 1989

• Miniature Ion Selective Electrodes

  Class I

  FDA 510(k) K830130 Active Cleared 7 Mar 1983

• Are these electrodes intended for single-use or can they be reused in a clinical chemistry lab?

  These electrodes are designed as reusable devices for laboratory use, specifically for measuring calcium ion concentrations in clinical chemistry applications. Since they are classified under FDA regulation 862.1145 and received FDA 510(k) clearance (K802856), their reuse is supported by regulatory intent, though proper maintenance and calibration per manufacturer guidelines are essential for accurate results.

• What types of clinical settings or specialties would primarily use these miniature ion selective electrodes?

  These electrodes are primarily intended for use in clinical chemistry laboratories, where precise measurement of calcium ion concentrations is critical. The regulatory data indicates they fall under the medical specialty description of *Clinical Chemistry*, making them suitable for settings like hospital labs, research facilities, or specialized diagnostic centers.

• How do I determine which specific model or size of these electrodes is needed for my application?

  The device data lists multiple registration numbers (e.g., 3005643513, 3014506106) and product codes (JFP) under FDA’s OpenFDA database, which correspond to different models or variants of the electrodes. While exact specifications like dimensions or sensitivity aren’t provided, these identifiers can be used to cross-reference with Ionetics, Inc.’s documentation or support team to confirm compatibility with your lab’s instrumentation or workflow.

• Are there any special storage requirements for these reusable electrodes?

  The provided data does not specify storage conditions such as temperature, humidity, or shelf life. For optimal performance and longevity, it is recommended to follow Ionetics, Inc.’s instructions for cleaning, storage, and maintenance. Proper handling—including avoiding contamination or physical damage—will be critical to ensure accurate ion measurements over repeated use.