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FDA 510(k)

ISE Electrodes

K-Number: K230890 · 2023-09-08

ApplicantRandox Laboratories, Ltd.
Decision Date2023-09-08
Product CodeCEM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ISE Electrodes is a medical device manufactured by Randox Laboratories, Ltd.. It received FDA 510(k) clearance on 2023-09-08 under approval number K230890. The device is classified under product code CEM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISE Electrodes?

ISE Electrodes is a medical device that received FDA 510(k) clearance on 2023-09-08. It is manufactured by Randox Laboratories, Ltd.. The 510(k) number is K230890.

When was ISE Electrodes approved by the FDA?

ISE Electrodes received FDA 510(k) clearance on 2023-09-08, under approval number K230890.

What company makes ISE Electrodes?

ISE Electrodes is manufactured by Randox Laboratories, Ltd..

What is the FDA product code for ISE Electrodes?

The FDA product code for ISE Electrodes is CEM.

Other Devices by Randox Laboratories, Ltd.

K152085Liquid CO2-2 (LCO2-2) K153435Direct HDL Cholesterol (HDL) K162200Randox RX Daytona Plus Magnesium (MG) K182042Randox Calcium (Ca) DEN240035ConcizuTrace™ ELISA

Related Devices (Code: CEM)

K200544SmartLyte® Plus Electrolyte Analyzer Na+/K+/Cl-/Ca++/Li+Diamond Diagnostics, Inc. K220396EasyStat 300Medica Corporation K241037ABL90 FLEX PLUS SystemRadiometer Medicals Aps K253491ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutionsRoche Diagnostics

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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