K-number	K221326
Device name	Nova Allegro HbA1c Assay, Nova Allegro Analyzer
Applicant	Nova Biomedical Corporation
Product code	LCP
Device class	Class II
Decision date	Nov 22, 2024
Decision	Substantially Equivalent
Regulation	864.7470

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Source

View the full FDA submission: accessdata.fda.gov

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Nova Allegro HbA1c Assay, Nova Allegro Analyzer

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