Panels › Clinical Chemistry › Product code PIG · Class 2
Acute Kidney Injury Test System
Regulation 862.1220
0510(k)s in 12 months (5 all time)
1recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in PIG
| Company | 510(k)s | Recalls |
|---|---|---|
| Astute Medical, Inc. | 3 | 0 |
| Biomérieux SA | 1 | 0 |
| Bioporto Diagnostic, Inc. | 1 | 0 |
| Bioporto Diagnostics A/S | 0 | 1 |
| 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 | K232761 |
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