510(k) K232761
- Device
- ProNephro AKI? (NGAL)
- Applicant
- Bioporto Diagnostic, Inc.
- 510(k) number
- K232761
- Product code
- PIG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-12-07
- Date received
- 2023-09-08
- 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
- Asger Dahlgaard
- Address
- 117 Fourth Ave. Suite 202 Needham MA US 02494 02494
FDA Registration Numbers#
- 3010739981
- 8020790
Source Documents#
Other 510(k) Records For Product Code PIG#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| DEN130031 | NEPHROCHECK TEST SYSTEM | Astute Medical, Inc. | 2014-09-05 |