FDA 510(k) Applications Submitted by MARION S GAIDE

FDA 510(k) Number Submission Date Device Name Applicant
K990172 01/19/1999 TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS WITH CYTO-STAT TETRACHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 MONOCLA COULTER CORP.
K990327 02/02/1999 RETICONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS COULTER CORP.
K961278 04/03/1996 COULTER STKS ANALYZER WITH CD4 & CD8 LYMPHOCYTE ANALYSIS COULTER CORP.
K962305 06/17/1996 CYTO-STAT TRICHROME CD45-FITC/CD8-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT IWTH ISOTYPIC CONTROL COULTER CORP.
K962768 06/17/1996 CYTO-STAT TRICHROME CD45-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANITBODY REAGENT W/ISOTYPIC CONTROL COULTER CORP.
K982166 06/19/1998 CYTO-STAT TRICHROME CD45-FITC/CD56-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1 COULTER CORP.
K982167 06/19/1998 CYTO-STAT TRICHROME CD45-FITC/CD19-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1 COULTER CORP.
K954688 10/11/1995 FLOW-COUNT COULTER FLUOROSPHERES COULTER CORP.
K964618 10/15/1996 CYTO-STAT TRICHROME CD8-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME MSIGGI-FITC/MSIGGI-RD1 COULTER CORP.
K984216 11/24/1998 IMMUNO-TROL CONTROL CELLS COULTER CORP.


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