Clearance Summary
NEPHROCHECK TEST SYSTEM received FDA 510(k) clearance under submission number DEN130031, sponsored by Astute Medical, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 2014-09-05.
- Submission: DEN130031
- Applicant / Sponsor: Astute Medical, Inc.
- Clearance pathway: Direct
- Review panel: Clinical Chemistry
- Device class: Class II
- Regulation citation: 21 CFR 862.1220
- Decision date: 2014-09-05
Classification & Regulation
This clearance is catalogued under FDA product code PIG and 21 CFR 862.1220, within the Clinical Chemistry review panel as a Class II device.