K252206

Substantially Equivalent

Nova Allegro UACR Assay, Nova Allegro Analyzer

Applicant: Nova Biomedical Corporation
Product code: CGX
Advisory panel: Clinical Chemistry
Date received: 2025-07-14
Decision date: 2026-01-09
Decision: Substantially Equivalent
Clearance type: Dual Track
Location: Walham, MA, US

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