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

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.

Clearance details

Applicant
Nova Biomedical Corporation
Product code
Code LCP
Advisory panel
Hematology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Dual Track
Location
Walham, MA, US
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