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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, Glycosylated Hemoglobin
510(k) Number K221326
Device Name Nova Allegro HbA1c Assay, Nova Allegro Analyzer
Applicant
Nova Biomedical Corporation
200 Prospect St.
Walham,  MA  02454
Applicant Contact Cesidio Tempesta
Correspondent
Nova Biomedical Corporation
200 Prospect St.
Walham,  MA  02454
Correspondent Contact Cesidio Tempesta
Regulation Number864.7470
Classification Product Code
LCP  
Subsequent Product Code
JQT  
Date Received05/06/2022
Decision Date 11/22/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Dual Track
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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