Cleared Special

ISE Electrodes

K230890 · Randox Laboratories, Ltd. · Chemistry
Sep 2023
Decision
161d
Days
Class 2
Risk

About This 510(k) Submission

K230890 is an FDA 510(k) clearance for the ISE Electrodes, a Electrode, Ion Specific, Potassium (Class II — Special Controls, product code CEM), submitted by Randox Laboratories, Ltd. (Crumlin, GB). The FDA issued a Cleared decision on September 8, 2023, 161 days after receiving the submission on March 31, 2023. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1600.

Submission Details

510(k) Number K230890 FDA.gov
FDA Decision Cleared SESE
Date Received March 31, 2023
Decision Date September 08, 2023
Days to Decision 161 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CEM — Electrode, Ion Specific, Potassium
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1600

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