The following data is part of a premarket notification filed by Astute Medical, Inc. with the FDA for Nephrocheck Test System.
| Device ID | K171482 |
| 510k Number | K171482 |
| Device Name: | NEPHROCHECK Test System |
| Classification | Acute Kidney Injury Test System |
| Applicant | Astute Medical, Inc. 3550 General Atomics Ct., Building 2, R 432 San Diego, CA 92121 |
| Contact | Karin Hughes |
| Correspondent | Karin Hughes Astute Medical, Inc. 3550 General Atomics Ct., Building 2, R 432 San Diego, CA 92121 |
| Product Code | PIG |
| CFR Regulation Number | 862.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-19 |
| Decision Date | 2017-11-16 |
| Summary: | summary |