CaloPix— 510(k) K250414

Substantially Equivalent

Tribun Health

FDA 510(k) clearance K250414 for CaloPix, Substantially Equivalent on 2025-05-14. Applicant: Tribun Health. Device class: 2.

Clearance details

Applicant: Tribun Health
Product code: Code QKQ
Device class: Class 2
Regulation: 21 CFR 864.3700
Advisory panel: Pathology
Date received: 2025-02-13
Decision date: 2025-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paris, FR

Download summary PDF View on FDA.gov ↗

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