NEPHROCHECK Test System— 510(k) K171482
Substantially EquivalentAstute Medical, Inc.
FDA 510(k) clearance K171482 for NEPHROCHECK Test System, Substantially Equivalent on 2017-11-16. Applicant: Astute Medical, Inc..
Clearance details
- Applicant
- Astute Medical, Inc.
- Product code
- Code PIG
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Diego, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.