Nova Allegro HbA1c Assay, Nova Allegro Analyzer— 510(k) K221326

Name: FDA 510(k) clearance K221326
Creator: U.S. Food and Drug Administration
Published: 2024-11-22

Substantially Equivalent

Nova Biomedical Corporation

FDA 510(k) clearance K221326 for Nova Allegro HbA1c Assay, Nova Allegro Analyzer, Substantially Equivalent on 2024-11-22. Applicant: Nova Biomedical Corporation. Device class: 2.

Clearance details

Applicant: Nova Biomedical Corporation
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 2022-05-06
Decision date: 2024-11-22
Decision: Substantially Equivalent
Clearance type: Dual Track
Location: Walham, MA, US

Download summary PDF View on FDA.gov ↗

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