FDA.report

510(k) K221813

Device
Nova Allegro UACR Assay, Nova Allegro Analyzer
Applicant
Nova Biomedical Corporation
510(k) number
K221813
Product code
CGX
Decision
Substantially Equivalent (SESE)
Decision date
2024-11-19
Date received
2022-06-22
Regulation
862.1225
Classification name
Alkaline Picrate, Colorimetry, Creatinine
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Dual Track
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Cesidio Tempesta
Address
200 Prospect St. Walham MA US 02454 02454

FDA Registration Numbers

Source Documents

510(k) summary PDF

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