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510(k) Data Aggregation

K Number

Validate with FDA (Live)

Device Name

VELO Respiratory Test

Manufacturer

Lex Diagnostics Limited

Date Cleared

2026-02-13

(252 days)

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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

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