GKZ
HemoScreen Hematology Analyzer
- Advisory panel
- Hematology
- Total cleared
- 379
Adverse events under product code GKZ
product code GKZ- Malfunction
- 1,205
- Total
- 1,205
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code GKZ
1–100 of 379- K243348 — Athelas Home
- K251249 — Tru Hematology Test
- K250943 — Sysmex XR-Series (XR-10) Automated Hematology Analyzer
- K251371 — Sysmex XR-Series (XR-20) Automated Hematology Analyzer
- K243283 — Alinity h-series System
- K240402 — Cito CBC System
- K240252 — UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis System
- K232946 — Yumizen H2500
- K240636 — HemoScreen Hematology Analyzer
- K230887 — Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer
- K230878 — QScout Lab; QScout RLD
- K222148 — HemoScreen Hematology Analyzer
- K220031 — Alinity h-series System
- K210346 — Sysmex XW-100 Automated Hematology Analyzer
- K211840 — Sight OLO
- K200828 — Athelas Home
- K193124 — Unicel DxH 800 Coulter Cellular Analysis System
- K190898 — Sight OLO
- K182886 — Cytomics FC 500 Series (MPL or MCL) Flow Cytometer
- K190294 — CELL-DYN Emerald 22 AL System
- K181475 — DxH 520 Hematology Instrument
- K182389 — Sysmex XN-L Automated Hematology Analyzer
- K181288 — Athelas One
- K180020 — HemoScreen Hematology Analyzer
- K171655 — cobas m 511 integrated hematology analyzer
- K172604 — XW-100 Automated Hematology Analyzer for CLIA Waived Use
- K170353 — ABX MICROS ES 60 OT and ABX MICROS ES 60 CT
- K162977 — ADVIA 2120i, ADVIA 2120
- K153538 — Dextramer CMV Kit
- K160538 — Sysmex XN-L Automated Hematology Analyzer
- K162414 — UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System
- K160429 — BC-5390 Auto Hematology Analyzer
- K151133 — PENTRA XLR
- K143577 — XW-100 Automated Hematology Analyzer, XW QC CHECK
- K143348 — BC-3600 Auto Hematology Analyzer
- K141161 — ABX MICROS ES 60 CT; (OPEN TUBE MODEL), (CLOSE TUBE MODEL)
- K141681 — SYSMEX XN SERIES
- K140911 — UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM/ UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEM
- K120771 — UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
- K112605 — SYSMEX XN-SERIES
- K111534 — ABACUS 3CP
- K112755 — ABACUS 5
- K110381 — CELL-DYN EMERALD 22 SYSTEM
- K102644 — ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120I
- K102064 — BD FACS SAMPLE PREP ASSISTANT III (SPA III)
- K100489 — DXH 300 COULTER CELLULAR ANALYSIS SYSTEM, DXH 300C COULTER CELLULAR ANALYSSI SYSTEM MODEL: 71772, 71771
- K090346 — ADVIA 2120/2120I BODY FLUIDS
- K093394 — BC-3200 AUTO HEMATOLOGY ANALYZER,M-30D DILUENT, M-30R RINSE, M-30CFL LYSE, M-30E-Z CLEANSER, M-30PROBE CLEANSER, BC-3D C
- K091313 — SYSMEX MODEL XT-4000I
- K090810 — THERMO SCIENTIFIC CYTO-CAL COUNT TUBES
- K090967 — BD MULTITEST 6-COLOR TBNK REAGENT, MODEL 644611
- K090013 — CHEMPAQ XBC ANALYZER
- K082091 — TRI T-STAT REAGENT ASSAY (DRIED FORM) MODEL 25107-00
- K081495 — CELL-DYN EMERALD SYSTEM
- K083420 — MEDONIC M SERIES
- K081930 — UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
- K081890 — SYSMEX XT-SERIES IG PARAMETER,SYSMEX XT-SERIES RET-HE PARAMETER
- K081610 — SYSMEX MODEL XS-1000IC AUTOMATED HEMATOLOGY ANALYZER
- K081213 — BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010
- K081526 — FLOWCARE TLG REAGENT
- K072869 — POINTCARE NOW SYSTEM
- K071562 — D3 HEMATOLOGY ANALYZER, MODEL D3
- K071967 — SYSMEX XE-5000
- K071681 — CYTOMICS FC 500 MPL FLOW CYTOMETER, MODEL # 626554
- K063407 — BC-3200 AUTO HEMATOLOGY ANALYZER
- K071141 — BD TRITEST CD3/CD4/CD45 WITH BD TRUCOUNT ABSOLUTE COUNT TUBES, MODEL 340402
- K071143 — BD TRITEST CD3/CD4/CD45, MODEL 340383
- K061616 — COULTER LH 780 HEMATOLOGY ANALYZER
- K062087 — BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 338962
- K060423 — CYAN DXD, MULTITEST CD8/CD4/CD3, CD3-FITC, CD3-RPE, CD3-APC AND FLUOROSPHERES
- K061574 — COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632
- K061667 — CELL-DYN RUBY SYSTEM
- K061150 — SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XT-SERIES
- K060375 — BD MULTITEST 6-COLOR TBNK REAGENT WITH BD TRUCOUNT TUBES WITH MODELS 337 AND 166
- K060656 — SYSMEX AUTOMATED HEMATOLOGY ANALYZER MODELS XS SERIES
- K053497 — GUAVA EZCD4 SYSTEM
- K053308 — ABX MICROS CRP 200, OPTION IM
- K050758 — CHEMPAQ XBC ANALYZER
- K052905 — MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER
- K051459 — SYSMEX MODEL XE-2100DC AUTOMATED HEMATOLOGY ANALYZER
- K050421 — MS 4/5 HEMATOLOGY ANALYZER
- K051199 — IPF (IMMATURE PLATELET FRACTION) PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER
- K051122 — ITAG MHC TETRAMER CMV ASSAY
- K050436 — MS 9/5 HEMATOLOGY ANALYZER
- K051215 — CELL-DYN SAPPHIRE SYSTEM
- K050589 — RET-HE PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER
- K050719 — ABX PENTRA DX 120: OPTION SPS EVOLUTION
- K050057 — COULTER LH 750 HEMATOLOGY ANALYZER
- K043215 — FLOWCARE PLG CD4 REAGENT
- K041882 — FLOWCARE SYSTEM
- K042724 — MODIFICATION TO COULTER LH 500 HEMATOLOGY ANALYZER
- K042173 — COULTER A T 5DIFF CAP PIERCE (CP)
- K041074 — BD FACSCANTO WITH BD FACSANTO SOFTWARE
- K042251 — BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM
- K040026 — BD FACS 7-COLOR SETUP BEADS
- K040725 — BD FACSCANTO SYSTEM
- K040073 — SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XE-2100 SERIES (XE-2100, XE-2100L)
- K032214 — MEDONIC CA620/530 HEMATOLOGY ANALYZER
- K030263 — IMMUNICON CELLTRACKS ANALYZER
- K032342 — COULTER LH 750 HEMATOLOGY ANALYZER
Data sourced from openFDA. This site is unofficial and independent of the FDA.