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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 7, 2023 | K232761 | ProNephro AKI (NGAL) Bioporto Diagnostic, Inc. | PIG |
| Jul 8, 2022 | K210793 | VIDAS NEPHROCHECK Biomérieux SA, FR | PIG |
| Nov 16, 2017 | K171482 | NEPHROCHECK Test System Astute Medical, Inc. | PIG |
| Jun 1, 2016 | K153165 | NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Astute Medical, Inc. | PIG |
| Sep 5, 2014 | DEN130031 | NEPHROCHECK TEST SYSTEM Astute Medical, Inc. | PIG |
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