Home / Device Classification / CGZ

CGZ — Electrode, Ion-Specific, Chloride Class II

FDA Device Classification

Classification Details

Product Code
CGZ
Device Class
Class II
Regulation Number
862.1170
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K182072ortho-clinical diagnosticsVITROS Chemistry Products Cl-Slides, VITROS Chemistry Products ECO2 Slides, VITROctober 30, 2018
K170320abbott laboratoriesAlinity c ICT Sample DiluentOctober 24, 2017
K162020ortho clinical diagnosticsVITROS Chemistry Products Cl- SlidesDecember 16, 2016
K082099ortho-clinical diagnosticsVITROS CHEMISTRY PRODUCTS CI-DT SLIDES; VITROS CHEMISTRY PRODUCTS DT CALIBRATOR August 21, 2008
K070889wallacAUTODELFIA NEONATAL IRT L KIT, MODEL B022-112April 14, 2008
K070531thermo fisher scientificISE MODULE AND BAR CODE READER ADDITION FOR THE DATAPRO CLINICAL CHEMISTRY ANALYSeptember 4, 2007
K060108roche diagnosticsCOBAS INTEGRA CHLORIDE ELCTRODE GEN.2February 16, 2006
K052027osmetechOPTI LION ELECTROLYTE ANALYZER, MODEL GD7200September 29, 2005
K020148phoenix diagnosticspHoenix ISE Reagents FOR Olympus AU Chemistry SystemsFebruary 4, 2002
K013451phoenix diagnosticsPHOENOIX ISE REAGENTS FOR ROCHE HITACHI, MODELS 700/900 SERIESDecember 18, 2001
K003664wallacDELFIA NEONATAL IRT KIT, MODEL A005-110February 14, 2001
K003668wallacAUTODELFIA NEONATAL IRT KIT, MODEL B005-112February 12, 2001
K993697wallacDELFIA NEONATAL IRT KITJune 9, 2000
K000926medicaEASYELECTROLYTE ANALYZER AND RAPIDLYTE ANALYZERMay 15, 2000
K991870a.p. total careELECTROLYTES (NA+, K+, CL-), PRODUCT NO'S 114-01, 114-02, 114-03July 30, 1999
K981270diametrics medicalIRMA BLOOD ANALYSIS SYSTEMMay 1, 1998
K980757instrumentation laboratoryILAB 600 CLINICAL CHEMISTRY SYSTEMApril 21, 1998
K980367abbott laboratoriesAEROSET SYSTEMApril 1, 1998
K973742sendx medicalSENDX 100 PH, BLOOD GAS AND ELECTROLYTE ANALYSIS SYSTEMDecember 3, 1997
K972004alko diagnosticISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMSJune 16, 1997