510(k) K171482
- Device
- NEPHROCHECK Test System
- Applicant
- Astute Medical, Inc.
- 510(k) number
- K171482
- Product code
- PIG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2017-11-16
- Date received
- 2017-05-19
- Regulation
- 862.1220
- Classification name
- Acute Kidney Injury Test System
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Karin Hughes
- Address
- 3550 General Atomics Ct., Bldg. 2, R 432 San Diego CA US 92121 92121
FDA Registration Numbers#
- 3010739981
- 8020790
Source Documents#
Other 510(k) Records For Product Code PIG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K232761 | ProNephro AKI™ (NGAL) | Bioporto Diagnostic, Inc. | 2023-12-07 |
| K210793 | VIDAS NEPHROCHECK | Biomérieux SA | 2022-07-08 |
| K153165 | NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit | Astute Medical, Inc. | 2016-06-01 |
| DEN130031 | NEPHROCHECK TEST SYSTEM | Astute Medical, Inc. | 2014-09-05 |
Legacy Summary#
summary
FDA Review#
Decision Summary