Super Urine Analyzer System

FDA 510(k) K870526 · Kyoto Daiichi Kagaku Co., Ltd.

Substantially Equivalent

510(k) numberK870526

Submission

Device name
Super Urine Analyzer System
Applicant
Kyoto Daiichi Kagaku Co., Ltd.
Kyoto, 601, JP
Received
February 6, 1987
Decision date
March 6, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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
K870708Glucoscot II Blood Glucose Test SystemLFR · Traditional 02/02/1988SE
K813056Automated Urinalysis SystemKQO · Traditional 05/05/1982SE

Questions and answers

When was Super Urine Analyzer System cleared by the FDA?

Super Urine Analyzer System (K870526) received a 510(k) decision of Substantially Equivalent on March 6, 1987, 28 days after the submission was received.

What is the product code of K870526?

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