K221813
- 510(k) number
- K221813
- Device name
- Nova Allegro UACR Assay, Nova Allegro Analyzer
- Applicant
- Nova Biomedical Corporation MA · US
- Product code
- CGX — Alkaline Picrate, Colorimetry, Creatinine
- Decision date
- 2024-11-19
- Date received
- 2022-06-22
- Decision
- Substantially Equivalent
- Clearance type
- Dual Track
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K221813.pdf
Official FDA record: K221813
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.