Cybow Reader, Models 300 & 720

FDA 510(k) K102188 · DFI Co., Ltd.

Substantially Equivalent

510(k) numberK102188

Submission

Device name
Cybow Reader, Models 300 & 720
Applicant
DFI Co., Ltd.
Gangnam-Gu, Seoul, KR
Received
August 3, 2010
Decision date
August 9, 2011
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

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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
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
K053253Hemocue Albumin 201 Analyzing SystemKQO · Traditional Hemocue AB02/17/2006SE

More from Hemocue AB

510(k)DeviceDecision
K181024DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent StripsJIL · Traditional 05/23/2018SE
K171521DUS R-50S (Urine Chemistry system)JIL · Traditional 02/16/2018SE
K052525Cybow 11 Series Reagent Strips for UrinalysisJIL · Traditional 03/29/2006SE

Questions and answers

When was Cybow Reader, Models 300 & 720 cleared by the FDA?

Cybow Reader, Models 300 & 720 (K102188) received a 510(k) decision of Substantially Equivalent on August 9, 2011, 371 days after the submission was received.

What is the product code of K102188?

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