NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit— 510(k) K153165
Substantially EquivalentAstute Medical, Inc.
FDA 510(k) clearance K153165 for NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit, Substantially Equivalent on 2016-06-01. 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
- Special
- Location
- San Diego, CA, US
Data sourced from openFDA. This site is unofficial and independent of the FDA.