ISE Electrodes— 510(k) K230890

Substantially Equivalent

Randox Laboratories, Ltd.

FDA 510(k) clearance K230890 for ISE Electrodes, Substantially Equivalent on 2023-09-08. Applicant: Randox Laboratories, Ltd.. Device class: 2.

Clearance details

Applicant: Randox Laboratories, Ltd.
Product code: Code CEM
Device class: Class 2
Regulation: 21 CFR 862.1600
Advisory panel: Clinical Chemistry
Date received: 2023-03-31
Decision date: 2023-09-08
Decision: Substantially Equivalent
Clearance type: Special
Location: Crumlin, GB

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.