Product code GKZ— Hematology
HemoScreen Hematology Analyzer
- Advisory panel
- Hematology
- Total cleared
- 380
Clearances under product code GKZ — page 2
101–200 of 380- K032342 — COULTER LH 750 HEMATOLOGY ANALYZER
- K032039 — IMMATURE GRANULOCYTE (IG) PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER
- K032524 — ADVIA 60 HEMATOLOGY ANALYZER
- K032000 — COULTER LH 500 HEMATOLOGY ANALYZER
- K032013 — COULTER ACT 5DIFF AL HEMATOLOGY ANALYZER
- K030828 — TETRACXP SYSTEM (SOFTWARE AND SYSTEM GUIDE)
- K030513 — CELL-DYN 1800 SYSTEM
- K030606 — COULTER LH 750 BODY FLUIDS APPLICATION
- K030291 — COULTER ACT 5DIFF AUTOLOADER (AL)
- K030799 — MICROS 60
- K030408 — CYTO-STAT TETRACHROME CD45-FIT/CD4-PE/CD3-PC5 MONOCLONAL ANTIBODY REAGENT, CYTO-STAT TETRACHROM CD45-FITC/CD56-PE/CD19-A
- K030144 — MODIFICATION TO PENTRA 60 AND PENTRA 60C+
- K024002 — PENTRA 80
- K022668 — ADVIA 120 HEMATOLOGY SYSTEM COMPLETE BLOOD COUNT (CBC) METHOD
- K022528 — IQ PRODUCTS TRIPLE-COLOR FLOW CYTOMETRY REAGENTS, IQ PRODUCTS CD45-FITC/CD4-PE/CD3-CYQ, IQ PRODUCTS CD45-FITC/CD8-PE/CDQ
- K022161 — MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632
- K022200 — PENTRA 120/PENTRA 120 RETIC OPTIONS SPS, MODEL PENTRA 120
- K021241 — SYSMEX XT-SERIES, MODEL XT-2000I AND XT-1800I
- K020496 — HPC (HEMATOPOIETIC PROGENITOR CELL) PARAMETER ON THE IMI CHANNEL OF THE SYSMEX SE-9500 AND XE-2100, AUTOMATED HEMATOLOGY
- K012934 — CELL-DYN 3200 SYSTEM WITH ABSOLUTE AND PERCENT RETICULOCYTE
- K012904 — ADVIA 120 HEMATOLOGY SYSTEM, CYANIDE-FREE HIGH DETERMINATION
- K011342 — COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632
- K010953 — CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAY
- K010765 — COULTER HMX ANALYZER, MODEL 6605523, COULTER HMX WITH AUTOLOADER, MODEL 6605526
- K003796 — ADVIA 120 HEMATOLOGY
- K003677 — ABX PENTRA 60C+ HEMATOLOGY ANALYZER
- K002646 — ABX MICROS CRP
- K000611 — STELLER CD61 ASSAY FOR USE ON THE IMAGN 2000 MICROVOLUME FLUORIMETER
- K000897 — CALIBRITE PERCP-CY5.5 BEADS AND FACSCOMP SOFTWARE
- K993356 — COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSES
- K992875 — SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZER
- K992511 — ABX PENTRA 60 HEMATOLOGY ANALYZER
- K992444 — MODIFICATION OF: CELL-DYN 1200 SYSTEM
- K992849 — QBC STAR CENTRIFUGAL HEMATOLOGY SYSTEM
- K991839 — ABX PENTRA 120 RETIC AUTOMATED HEMATOLOGY ANALYZER
- K991605 — CELL-DYN 3500 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION (IRF), CELL-DYN 3700 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION
- K991539 — EXCELL 22
- K991142 — CELL-DYN 1200 SYSTEM
- K991402 — DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE-CY5, CLONE UCHT1 & DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE, CLONE UCHT1
- K991454 — MOUSE IGG1 NEGATIVE CONTROLS
- K990327 — RETICONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS
- K990172 — TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS WITH CYTO-STAT TETRACHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 MONOCLA
- K990352 — COULTER AC T DIFF 2 ANALYZER
- K990311 — VEGA RETIC AUTOMATED HEMATOLOGY ANALYZER
- K982167 — CYTO-STAT TRICHROME CD45-FITC/CD19-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1
- K982166 — CYTO-STAT TRICHROME CD45-FITC/CD56-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD1
- K983562 — MASCOT MD HEMATOLOGY ANALYZER/ MODEL MD 700
- K982172 — CYTO-STAT CD3-FITC/CD56-RDI MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT/COULTER CLONE MSIGGI-RD1/MSIGGI-FITC ISOTYPIC COL
- K982802 — BAYER ADVIA 60 HEMATOLOGY SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)
- K981568 — MASCOT MD HEMATOLOGY ANALYZER, MODEL MD 800
- K980635 — DAKO MOUSE ANTI-HUMAN B-CELL, CD19/RPE-CY5, CLONE HD37
- K982231 — STATUSFLOW
- K981342 — ABBOTT CELL-DYN 4000 IMMUNOPIT (CD61) ASSAY
- K980858 — MULTITEST CD3/CD16+56/CD45/CD19 REAGENT AND MULTITEST IMK KIT LYSING SOLUTION
- K980614 — ABBOTT CELL-DYN 3000 SERIES HEMATOLOGY SYSTEMS
- K974360 — MULTITEST CD3/CD8/CD45/CD4
- K973483 — FACSCOMP SOFTWARE AND CALIBRITE BEADS FOR USE IN FLOW CYTOMETER INSTRUMENT SET
- K971205 — TRI TEST REAGENT CD4 FIT C/CD8 PE/CD3 PERCP WITH TRUCOUNT ABSOLUTE COUNT TUBES
- K971110 — TRITEST REAGENT CD3 FITC/CD16+CD56 PE/CD45 PERCP;WITH TRUCOUNT ABSOLUTE COUNT TUBES
- K965053 — TRITEST REAGENT CD3 FITC/CD4 PE/CD45 PERCP; TRUCOUNT ABSOLUTE COUNT TUBES
- K970326 — TRITEST REAGENT CD3 FITC/CD8 PE/CD45 PERCP;WITH TRUCOUNT ABSOLUTE COUNT TUBES
- K973634 — COULTER AC.T DIFF ANALYZER
- K970742 — TRITEST CD3 FITC/CD19 PE/CD45 PERCP REAGENT WITH TRUCOUNT ABSOLUTE COUNT TUBES
- K972354 — ABBOTT CELL-DYN 3200 SYSTEM
- K970836 — TRUCOUNT ABSOLUTE COUNT TUBES/COUNTING CONTROL BEADS
- K971736 — SYSMEX IMMATURE RETICULOCYTE FRACTION (IRF) PARAMETER
- K971152 — ABBOTT CELL-DYN 4000 IMMATURE RETICULOCYTE FRACTION (IRF)
- K951459 — ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATE
- K964974 — MOUSE ANTI-HUMAN CD45, LEUCOCYTE COMMON ANTIGEN (LCA)/FITC AND CD14, MONOCYTE/RPE
- K965232 — CALTAG CAL-LYSE
- K951632 — ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE)
- K960072 — SPIRIT HEMATOLOGY SYSTEM MODEL LE, CP, & AX
- K964988 — COULTER AC.T SERIES ANALYZER
- K963263 — TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS AND CYTO-STAT TERTRACHROME CD45-FITC/CD4-RDI/CD8-ECD/CD3-PC5
- K964754 — ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATE
- K964856 — CD3 FITC/CD19 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION
- K962305 — CYTO-STAT TRICHROME CD45-FITC/CD8-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT IWTH ISOTYPIC CONTROL
- K962768 — CYTO-STAT TRICHROME CD45-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANITBODY REAGENT W/ISOTYPIC CONTROL
- K964618 — CYTO-STAT TRICHROME CD8-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME MSIGGI-FITC/MSIGGI-RD1
- K963963 — MULTISET SOFTWARE FOR AUTOMATED FLOW CYTOMETRIC DATA ANALYSIS
- K963954 — CD 19 R-PE, CD19 TRI-COLOR MONOCLONAL ANTIBODY
- K962633 — VEGA HEMATOLOGY ANALYZER
- K961439 — ABBOTT CELL-DYN 4000 SYSTEM
- K955715 — CELL DYN 3500 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER (MODIFICATION)
- K954594 — RETICULOCYTE METHOD, RBC INDICES
- K961278 — COULTER STKS ANALYZER WITH CD4 & CD8 LYMPHOCYTE ANALYSIS
- K961701 — MOUSE ANTI-HUMAN CD3, T-CELL, FITC AND CD4, T-CELL, (HELPER/INDUCER) RPE
- K961610 — R & D SYSTEMS' WHOLE BLOOD FLOW CONTROL, (R & D - WBFC)
- K960531 — MOUSE ANTI-HUMAN CD3, T-CELL/FITC & CD19, B-CELL/RPE
- K961435 — MOUSE ANTI-HUMAN CD2, T-CELL/FITC AND MOUSE ANTI-HUMAN CD19, B-CELL/RPE
- K961623 — FACSCOMP SOFTWARE & CALIBRITE 3 COLOR BEADS KIT/CALIBRITE PERCP BEADS
- K942525 — MEDICOUNT DEKA HEMATOLOGY ANALYZER
- K955673 — CELL DYN 3000 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER (MODIFICATION)
- K960827 — QBC ACCUTUBE(423406)/QBC AUTOREAD(424571)
- K960887 — MOUSE ANTI-HUMAN CD4, T-CELL, HELPER/INDUCER/FITC & CD8, T-CELL, SUPPRESSOR/CYTOTOXIC/RPE
- K950568 — ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE)
- K950625 — ORTHO-MUNE OK-COMBO CD40FITC/CD8-PE (OKT4A/OKT8) MONOCLONAL ANTIBODY (MURINE)
- K951100 — ORTHO-MUNE OK-COMBO CD3-FITC/CD19-PE (OKT3/OKB19A MONOLCLONAL ANTIBODY (MURINE)
- K953116 — WHITE IRIS LEUKOCYTE DIFFERENTIAL ANALYZER
- K950482 — ORTHO-MUNE OK-COMVO CD3-FITC/CD8-PE (OKT 3/OKT8) MONOCLONAL ANTIBODY (MURINE)
Data sourced from openFDA. This site is unofficial and independent of the FDA.