NEPHROCHECK TEST SYSTEM— 510(k) DEN130031

Unknown

Astute Medical, Inc.

FDA 510(k) clearance DEN130031 for NEPHROCHECK TEST SYSTEM, Unknown on 2014-09-05. Applicant: Astute Medical, Inc.. Device class: 2.

Clearance details

Applicant: Astute Medical, Inc.
Product code: Code PIG
Device class: Class 2
Regulation: 21 CFR 862.1220
Advisory panel: Clinical Chemistry
Date received: 2013-06-05
Decision date: 2014-09-05
Decision: Unknown
Clearance type: Direct
Location: San Diego, CA, US

View on FDA.gov ↗

Recent devices under product code PIG

K232761 — ProNephro AKI (NGAL)2023-12-07
K210793 — VIDAS NEPHROCHECK2022-07-08
K171482 — NEPHROCHECK Test System2017-11-16
K153165 — NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit2016-06-01

Data sourced from openFDA. This site is unofficial and independent of the FDA.