510(k) DEN130031
- Device
- NEPHROCHECK TEST SYSTEM
- Applicant
- Astute Medical, Inc.
- 510(k) number
- DEN130031
- Product code
- PIG
- Decision
- Unknown (DENG)
- Decision date
- 2014-09-05
- Date received
- 2013-06-05
- Regulation
- 862.1220
- Classification name
- Acute Kidney Injury Test System
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- KARIN HUGHES
- Address
- 3550 General Atomics Ct. Bldg. 2, R 636 San Diego CA US 92121 92121
FDA Registration Numbers#
- 3010739981
- 8020790
Source Documents#
510(k) summary PDF not indicated by FDA
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 |
| K171482 | NEPHROCHECK Test System | Astute Medical, Inc. | 2017-11-16 |
| K153165 | NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit | Astute Medical, Inc. | 2016-06-01 |