Aution Jet AJ-4270 Urine Analyzer

FDA 510(k) K030600 · International Remote Imaging Systems

Substantially Equivalent

510(k) numberK030600

Submission

Device name
Aution Jet AJ-4270 Urine Analyzer
Applicant
International Remote Imaging Systems
North Attleboro, MA, US
Received
February 25, 2003
Decision date
July 11, 2003
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
K091472Uritest 50 and Uritest 500 Urine AnalyzerKQO · Traditional Arj Medical, Inc.04/27/2010SE
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

More from ACON Laboratories, Inc.

510(k)DeviceDecision
K013783Aution Max AX-4280 Urinalysis SystemKQO · Traditional 01/18/2002SE
K945913Irispec Urine Chemistry Control Part a and BJJW · Traditional 04/05/1995SE

Questions and answers

When was Aution Jet AJ-4270 Urine Analyzer cleared by the FDA?

Aution Jet AJ-4270 Urine Analyzer (K030600) received a 510(k) decision of Substantially Equivalent on July 11, 2003, 136 days after the submission was received.

What is the product code of K030600?

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