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GKH — Apparatus, Automated Blood Cell Diluting Class I

FDA Device Classification

Classification Details

Product Code
GKH
Device Class
Class I
Regulation Number
864.5240
Submission Type
Review Panel
HE
Medical Specialty
Hematology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K100684veridexCELLTRACKS AUTOPREP SYSTEM MODEL:9541August 26, 2010
K040077immuniconIMMUNICON CELLTRACKS AUTOPREP SYSTEMMarch 12, 2004
K022512immuniconCELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518September 30, 2002
K021150beckman coulterCOULTER CELLPREPJune 11, 2002
K935953coulterCOULTER MULTI Q PREPMarch 11, 1994
K923530coulter electronicsCOULTER MULTI-Q-PREPOctober 14, 1992
K904795bd becton dickinson vacutainer systems preanalyticFACSPREP ROBOTIC SAMPLE PREPARATION SYSTEMDecember 31, 1990
K882767toa medical electronics usaSYSMEX DD-100 WHOLE BLOOD DILUTION SYSTEMJuly 18, 1988
K852373abbott diagnosticsAD150, AUTOMATED HEMATOLOGY DILUTORJuly 5, 1985
K842747r and d systemsHYCEL DILUTOR, VARIOUS MODELS/MULTIOctober 1, 1984
K842446abbott diagnosticsDILU-MATIC 140September 6, 1984
K823522innovative medical systemsDILULAB 230December 28, 1982
K791644royco instrumentsROYCO MODEL 371 SUPER DILUTORSeptember 19, 1979
K761137ortho diagnosticsMICROSAMPLE BLOOD COLLECTION DEVICEFebruary 7, 1977