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Coulter Corp.

FDA 510(k) & PMA Approved Devices — 51 products

Total Devices51
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K993356 COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSESGKZ2000-04-20 View
510(k) K991070 COULTER Z2 ANALYZERGKL1999-05-11 View
510(k) K990327 RETICONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMSGKZ1999-04-26 View
510(k) K990172 TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS WITH CYTO-STAT TETRACHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 MONOCLAGKZ1999-04-13 View
510(k) K990352 COULTER AC T DIFF 2 ANALYZERGKZ1999-04-01 View
510(k) K984216 IMMUNO-TROL CONTROL CELLSJPK1999-03-16 View
510(k) K982167 CYTO-STAT TRICHROME CD45-FITC/CD19-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1GKZ1998-11-09 View
510(k) K982166 CYTO-STAT TRICHROME CD45-FITC/CD56-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1GKZ1998-11-05 View
510(k) K982172 CYTO-STAT CD3-FITC/CD56-RDI MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT/COULTER CLONE MSIGGI-RD1/MSIGGI-FITC ISOTYPIC COLGKZ1998-09-24 View
510(k) K973634 COULTER AC.T DIFF ANALYZERGKZ1997-10-29 View
510(k) K971469 COULTER ACT TRON CELL CONTROLJPK1997-06-30 View
510(k) K964988 COULTER AC.T SERIES ANALYZERGKZ1997-03-06 View
510(k) K963263 TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS AND CYTO-STAT TERTRACHROME CD45-FITC/CD4-RDI/CD8-ECD/CD3-PC5GKZ1997-01-22 View
510(k) K962768 CYTO-STAT TRICHROME CD45-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANITBODY REAGENT W/ISOTYPIC CONTROLGKZ1997-01-06 View
510(k) K962305 CYTO-STAT TRICHROME CD45-FITC/CD8-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT IWTH ISOTYPIC CONTROLGKZ1997-01-06 View
510(k) K964618 CYTO-STAT TRICHROME CD8-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME MSIGGI-FITC/MSIGGI-RD1GKZ1996-12-23 View
510(k) K962988 COULTER GEN-S SYSTEMGKL1996-10-30 View
510(k) K961278 COULTER STKS ANALYZER WITH CD4 & CD8 LYMPHOCYTE ANALYSISGKZ1996-07-22 View
510(k) K954688 FLOW-COUNT COULTER FLUOROSPHERESGKZ1996-02-29 View
510(k) K955334 COULTER LINEARITY CONTROLJPK1996-02-08 View
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