NEPHROCHECK Test System
FDA 510(k) clearance K171482 · decided 2017-11-16
Clearance details
- K-number
- K171482
- Device name
- NEPHROCHECK Test System
- Applicant
- Astute Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2017-05-19
- Decision date
- 2017-11-16
- Days to decision
- 181 days
- Clearance type
- Traditional
- Product code
- PIG
- Device class
- 2
- Regulation number
- 862.1220
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ProNephro AKI™ (NGAL) (K232761) | Bioporto Diagnostic, Inc. | 2023-12-07 |
| VIDAS NEPHROCHECK (K210793) | Biomérieux SA | 2022-07-08 |
| NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit (K153165) | Astute Medical, Inc. | 2016-06-01 |
| NEPHROCHECK TEST SYSTEM (DEN130031) | Astute Medical, Inc. | 2014-09-05 |
Recalls involving this device
No recalls on record reference this clearance.