FDA Product Code
FDA Product Code PIG — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1220
510(k) Clearances — 5 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K232761 | ProNephro AKI (NGAL) | Bioporto Diagnostic, Inc. | 2023-12-07 | Traditional | PDF ↗ |
| K210793 | VIDAS NEPHROCHECK | Biomérieux SA | 2022-07-08 | Traditional | PDF ↗ |
| K171482 | NEPHROCHECK Test System | Astute Medical, Inc. | 2017-11-16 | Traditional | PDF ↗ |
| K153165 | NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit | Astute Medical, Inc. | 2016-06-01 | Special | PDF ↗ |
| DEN130031 | NEPHROCHECK TEST SYSTEM | Astute Medical, Inc. | 2014-09-05 | Direct | — |
Product code PIG · Class II · Clinical Chemistry. Data: openFDA.