510(k) K153165

Device: NEPHROCHECK Test Kit, ASTUTE140 Meter, NEPHROCHECK Liquid Controls Kit, NEPHROCHECK Calibration Verification (Cal Vers) Kit
Applicant: ASTUTE MEDICAL, INC
510(k) number: K153165
Product code: PIG
Decision: Substantially Equivalent (SESE)
Decision date: 2016-06-01
Date received: 2015-11-02
Regulation: 862.1220
Classification name: Acute Kidney Injury Test System
Medical specialty: Clinical Chemistry
Review panel: Clinical Chemistry
Device class: 2
Clearance type: Special
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: Karin Hughes
Address: 3550 General Atomics Ct., Bldg. 2, R 432 San Diego CA US 92121 92121

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K232761	ProNephro AKI™ (NGAL)	Bioporto Diagnostic, Inc.	2023-12-07
K210793	VIDAS NEPHROCHECK	Biomérieux SA	2022-07-08
K171482	NEPHROCHECK Test System	Astute Medical, Inc.	2017-11-16
DEN130031	NEPHROCHECK TEST SYSTEM	Astute Medical, Inc.	2014-09-05

summary

Decision Summary