FDA 510(k) Applications Submitted by COULTER CORP.

FDA 510(k) Number Submission Date Device Name Applicant
K955016 11/02/1995 4C PLUS COULTER CELL CONTROL COULTER CORP.
K955334 11/20/1995 COULTER LINEARITY CONTROL COULTER CORP.
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.
K982172 06/19/1998 CYTO-STAT CD3-FITC/CD56-RDI MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT/COULTER CLONE MSIGGI-RD1/MSIGGI-FITC ISOTYPIC COL COULTER CORP.
K993356 10/06/1999 COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSES COULTER CORP.
K963263 08/20/1996 TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS AND CYTO-STAT TERTRACHROME CD45-FITC/CD4-RDI/CD8-ECD/CD3-PC5 COULTER CORP.
K990352 02/05/1999 COULTER AC T DIFF 2 ANALYZER COULTER CORP.
K991070 03/31/1999 COULTER Z2 ANALYZER COULTER CORP.
K971469 04/22/1997 COULTER ACT TRON CELL CONTROL COULTER CORP.
K962988 08/01/1996 COULTER GEN-S SYSTEM COULTER CORP.
K973634 09/24/1997 COULTER AC.T DIFF ANALYZER COULTER CORP.
K964988 12/13/1996 COULTER AC.T SERIES ANALYZER COULTER CORP.


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