K-number	K221813
Device name	Nova Allegro UACR Assay, Nova Allegro Analyzer
Applicant	Nova Biomedical Corporation
Product code	CGX
Device class	Class II
Decision date	Nov 19, 2024
Decision	Substantially Equivalent
Regulation	862.1225

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Source

View the full FDA submission: accessdata.fda.gov

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Nova Allegro UACR Assay, Nova Allegro Analyzer

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