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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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