ConcizuTrace ELISA— 510(k) DEN240035

Unknown

Randox Laboratories, Ltd.

FDA 510(k) clearance DEN240035 for ConcizuTrace ELISA, Unknown on 2025-05-22. Applicant: Randox Laboratories, Ltd.. Device class: 2.

Clearance details

Applicant: Randox Laboratories, Ltd.
Product code: Code SES
Device class: Class 2
Regulation: 21 CFR 864.7298
Advisory panel: Hematology
Date received: 2024-07-01
Decision date: 2025-05-22
Decision: Unknown
Clearance type: Direct
Location: Crumlin, GB

View on FDA.gov ↗

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