Uritest 50 and Uritest 500 Urine Analyzer

FDA 510(k) K091472 · Arj Medical, Inc.

Substantially Equivalent

510(k) numberK091472

Submission

Device name
Uritest 50 and Uritest 500 Urine Analyzer
Applicant
Arj Medical, Inc.
Oldsmar, FL, US
Received
May 18, 2009
Decision date
April 27, 2010
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KQO – Automated Urinalysis System
Device class
Class I (low risk)
Regulation
21 CFR 862.2900
Specialty
Clinical Chemistry

Other 510(k)s with product code KQO

510(k)DeviceApplicantDecision
K141874Uriscan OptimaKQO · Traditional Yd Diagnostics Corp.05/28/2015SE
K142543Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube…KQO · Traditional ACON Laboratories, Inc.05/11/2015SE
K140717Clinitek Novus; Automated Urine Chemistry Analyzer, 10 Urinalysis Cassette, Calibration…KQO · Traditional Siemens Healthcare Diagnostics11/17/2014SE
K121456Aution Hybrid AU-4050 Fully Automated Integrated Urine Analyzer System; Uriflet S 9HA…KQO · Traditional Arkray, Inc.02/01/2013SE
K102188Cybow Reader, Models 300 & 720KQO · Traditional DFI Co., Ltd.08/09/2011SE
K101852Chem Velocity Automated Urine Chemistry System, Strips and Calchek KitKQO · Traditional Iris International Inc., A Division of Iris Iris I03/23/2011SE
K093555Cobas U411 Test SystemKQO · Traditional Roche Diagnostics04/02/2010SE
K093098Aution Max Model AX-4030 Urinalysis SystemKQO · Special Arkray, Inc.12/23/2009SE
K070929Acon U120 Urine Analyzer, Model U111-101KQO · Traditional ACON Laboratories, Inc.07/30/2007SE
K053253Hemocue Albumin 201 Analyzing SystemKQO · Traditional Hemocue AB02/17/2006SE

More from Hemocue AB

510(k)DeviceDecision
K052719Uritest 10 Urinalysis Reagent StripsCDM · Traditional 12/05/2006SE
K052708Pylo-PlusLYR · Traditional 05/01/2006SE

Questions and answers

When was Uritest 50 and Uritest 500 Urine Analyzer cleared by the FDA?

Uritest 50 and Uritest 500 Urine Analyzer (K091472) received a 510(k) decision of Substantially Equivalent on April 27, 2010, 344 days after the submission was received.

What is the product code of K091472?

The FDA product code is KQO – Automated Urinalysis System, a Class I (low risk) device regulated under 21 CFR 862.2900.