ISE Electrodes— 510(k) K230890
Substantially EquivalentRandox Laboratories, Ltd.
FDA 510(k) clearance K230890 for ISE Electrodes, Substantially Equivalent on 2023-09-08. Applicant: Randox Laboratories, Ltd..
Clearance details
- Applicant
- Randox Laboratories, Ltd.
- Product code
- Code CEM
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Crumlin, GB
Data sourced from openFDA. This site is unofficial and independent of the FDA.