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GKL — Counter, Cell, Automated (Particle Counter) Class II

FDA Device Classification

Classification Details

Product Code
GKL
Device Class
Class II
Regulation Number
864.5200
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K152776advanced instrumentsGlocyte Automated Cell Counter SystemMay 27, 2016
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K050235iris internationalIQ 200 URINE ANALYZER BODY FLUIDS MODULEMarch 23, 2005
K032677sysmex americaSYSMEX POCH-100IFebruary 11, 2004
K022331bayer diagnosticsADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHODSeptember 11, 2002
K001683sysmex corporation of americaSYSMEX R-500August 21, 2000
K991070coulterCOULTER Z2 ANALYZERMay 11, 1999
K981950sysmexSYSMEX R-3500, AUTOMATED RETICCULOCYTE ANALYZER, MODEL R-3500November 3, 1998
K981761sysmexSYSMEX KX-21, AUTOMATED HEMATOLOGY ANALYZERAugust 14, 1998
K971998bayerADVIA 120 HEMATOLOGY SYSTEM, IN VITRO DIAGNOSTIC SYSTEMAugust 29, 1997
K964375sysmexSYSMEX SE/RAM-1March 13, 1997
K962988coulterCOULTER GEN-S SYSTEMOctober 30, 1996
K954607bayerRETICULOCYTE METHODAugust 30, 1996
K954006intl. remote imaging systemsYELLOW IRIS URINALYSIS WORKSTATION W/IRISCOPE BODY FLUID ANALYSIS CAPABILITYMarch 12, 1996
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K923121bd becton dickinson vacutainer systems preanalyticQBC HEMACAN HEMATOLOGY SYSTEMSeptember 22, 1992