K232761
- 510(k) number
- K232761
- Device name
- ProNephro AKI (NGAL)
- Applicant
- Bioporto Diagnostic, Inc. MA · US
- Product code
- PIG — Acute Kidney Injury Test System
- Decision date
- 2023-12-07
- Date received
- 2023-09-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K232761.pdf
Official FDA record: K232761
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.