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510(k) K842237

Device
CLINITEK 200 SEMI-AUTOMATED URINALYSIS
Applicant
MILES LABORATORIES, INC.
510(k) number
K842237
Product code
KQO  
Decision
Substantially Equivalent (SESE)
Decision date
1984-08-15
Date received
1984-06-05
Regulation
862.2900
Classification name
Automated Urinalysis System
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KQO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K141874URISCAN OPTIMAYd Diagnostics Corp.2015-05-28
K142543Mission U120 Ultra Urine Analyzer, Mission Liquid Urine Controls, Mission Liquid Diptube Urine ControlACON Laboratories, Inc.2015-05-11
K140717CLINITEK NOVUS; AUTOMATED URINE CHEMISTRY ANALYZER, 10 URINALYSIS CASSETTE, CALIBRATION KITSiemens Healthcare Diagnostics2014-11-17
K121456AUTION HYBRID AU-4050 FULLY AUTOMATED INTEGRATED URINE ANALYZER SYSTEM; URIFLET S 9HA URINE TEST STRIPS; AUTION CONTROLArkray, Inc.2013-02-01
K102188CYBOW READER, MODELS 300 & 720DFI Co., Ltd.2011-08-09
K101852CHEM VELOCITY AUTOMATED URINE CHEMISTRY SYSTEM, STRIPS AND CALCHEK KITIris International Inc., A Division of Iris Iris I2011-03-23
K091472URITEST 50 AND URITEST 500 URINE ANALYZERArj Medical, Inc.2010-04-27
K093555COBAS U411 TEST SYSTEMRoche Diagnostics2010-04-02
K093098AUTION MAX MODEL AX-4030 URINALYSIS SYSTEMArkray, Inc.2009-12-23
K070929ACON U120 URINE ANALYZER, MODEL U111-101ACON Laboratories, Inc.2007-07-30
K053253HEMOCUE ALBUMIN 201 ANALYZING SYSTEMHemocue AB2006-02-17
K051526URITEK-720+ URINE ANALYZERTeco Diagnostics2005-08-16
K042421URITEK 151 URINE ANALYZER, MODEL TC-151Teco Diagnostics2005-05-09
K031947BAYER CLINITEK STATUS ANALYZERBayer Healthcare, LLC2003-12-19
K030600AUTION JET AJ-4270 URINE ANALYZERInternational Remote Imaging Systems2003-07-11

Legacy Summary#

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FDA Review#

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