510(k) K232761 · PIG Acute Kidney Injury Test System
ProNephro AKI (NGAL)
| Applicant | Bioporto Diagnostic, Inc., Needham MA, US |
| Decision | Substantially Equivalent, Dec 7, 2023 |
| Received | Sep 8, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K232761
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 12, 2026 | Bioporto Diagnostics A/S ProNephro AKI (NGAL) Reagent Kit (100 tests). IVD Acute Kidney Injury Test System. Open, Classified |
PIG | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.