Stripmax 1210 Urine Chemistry Analyzer, Urimate Reagent Strip for Urinalysis

FDA 510(k) K012829 · Biocare Corp.

Substantially Equivalent

510(k) numberK012829

Submission

Device name
Stripmax 1210 Urine Chemistry Analyzer, Urimate Reagent Strip for Urinalysis
Applicant
Biocare Corp.
Edina, MN, US
Received
August 23, 2001
Decision date
November 2, 2001
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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

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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
K122307Diavue Prudential Blood Glucose Monitoring SystemNBW · Traditional 04/05/2013SE
K091414Vtrust Blood Pressure Monitor, Model Vtrust 701DHDXN · Traditional 10/21/2009SE
K002855Biolyte 2000 Na+,K+,Cl-/Li+Electrolyte AnalyzerJGS · Traditional 10/12/2000SE

Questions and answers

When was Stripmax 1210 Urine Chemistry Analyzer, Urimate Reagent Strip for Urinalysis cleared by the FDA?

Stripmax 1210 Urine Chemistry Analyzer, Urimate Reagent Strip for Urinalysis (K012829) received a 510(k) decision of Substantially Equivalent on November 2, 2001, 71 days after the submission was received.

What is the product code of K012829?

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