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510(k) K893628

Device
OLYMPUS ISE MODULE FOR AU5000
Applicant
OLYMPUS CORP.
510(k) number
K893628
Product code
CGZ  
Decision
Substantially Equivalent (SESE)
Decision date
1989-08-11
Date received
1989-05-11
Regulation
862.1170
Classification name
Electrode, Ion-specific, Chloride
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
LAURA STORMS-TYLER
Address
4 Nevada Dr. Lake Success NY US 11042 11042

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CGZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K182072VITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROS Chemistry Products GLU SlidesOrtho-Clinical Diagnostics, Inc.2018-10-30
K170320Alinity c ICT Sample DiluentAbbott Laboratories2017-10-24
K162020VITROS Chemistry Products Cl- SlidesOrtho Clinical Diagnostics2016-12-16
K082099VITROS CHEMISTRY PRODUCTS CI-DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CI-DT SLIDES:131 4905Ortho-Clinical Diagnostics, Inc.2008-08-21
K070889AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112Wallac OY2008-04-14
K070531ISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL CHEMISTRY ANALYZERThermo Fisher Scientific2007-09-04
K060108COBAS INTEGRA CHLORIDE ELCTRODE GEN.2Roche Diagnostics Corp.2006-02-16
K052027OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200Osmetech, Inc.2005-09-29
K020148pHoenix ISE Reagents FOR Olympus AU Chemistry SystemsPhoenix Diagnostics, Inc.2002-02-04
K013451PHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIESPhoenix Diagnostics, Inc.2001-12-18
K003664DELFIA NEONATAL IRT KIT, MODEL A005-110Wallac OY2001-02-14
K003668AUTODELFIA NEONATAL IRT KIT, MODEL B005-112Wallac OY2001-02-12
K993697DELFIA NEONATAL IRT KITWallac OY2000-06-09
K000926EASYELECTROLYTE ANALYZER AND RAPIDLYTE ANALYZERMedica Corp.2000-05-15
K991870ELECTROLYTES (NA+, K+, CL-), PRODUCT NO'S 114-01, 114-02, 114-03A.P. Total Care, Inc.1999-07-30

Legacy Summary#

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FDA Review#

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