Nova Allegro UACR Assay, Nova Allegro Analyzer— 510(k) K221813

Name: FDA 510(k) clearance K221813
Creator: U.S. Food and Drug Administration
Published: 2024-11-19

Substantially Equivalent

Nova Biomedical Corporation

FDA 510(k) clearance K221813 for Nova Allegro UACR Assay, Nova Allegro Analyzer, Substantially Equivalent on 2024-11-19. Applicant: Nova Biomedical Corporation. Device class: 2.

Clearance details

Applicant: Nova Biomedical Corporation
Product code: Code CGX
Device class: Class 2
Regulation: 21 CFR 862.1225
Advisory panel: Clinical Chemistry
Date received: 2022-06-22
Decision date: 2024-11-19
Decision: Substantially Equivalent
Clearance type: Dual Track
Location: Walham, MA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.