VELO Respiratory Test— 510(k) K251742

Substantially Equivalent

Lex Diagnostics Limited

FDA 510(k) clearance K251742 for VELO Respiratory Test, Substantially Equivalent on 2026-02-13. Applicant: Lex Diagnostics Limited. Device class: 2.

Clearance details

Applicant: Lex Diagnostics Limited
Product code: Code QOF
Device class: Class 2
Regulation: 21 CFR 866.3981
Advisory panel: Microbiology
Date received: 2025-06-06
Decision date: 2026-02-13
Decision: Substantially Equivalent
Clearance type: Dual Track
Location: Melbourn, 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.