Anesthesiology
Review Panel
- CardiovascularReview Panel
- ChemistryReview Panel
- DentalReview Panel
- Ear, Nose, ThroatReview Panel
- Gastroenterology and UrologyReview Panel
- General HospitalReview Panel
- HematologyReview Panel
- MiscellaneousMiscellaneous
- Subpart B—Biological StainsCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart C—Cell And Tissue Culture ProductsCFR Sub-Part
- Subpart C—Clinical Laboratory InstrumentsCFR Sub-Part
- Subpart E—Specimen Preparation ReagentsCFR Sub-Part
- Subpart F—Automated and Semi-Automated Hematology DevicesCFR Sub-Part
- GKFInstrument, Hematocrit, Automated2Product Code
- GKHApparatus, Automated Blood Cell Diluting1Product Code
- GKJSpinner, Slide, Automated1Product Code
- GKLCounter, Cell, Automated (Particle Counter)2Product Code
- GKNTimer, Clot, Automated2Product Code
- GIZPlasma, Control, Normal2Product Code
- GKBDevice, Automated Sedimentation Rate1Product Code
- GGCControl, Plasma, Abnormal2Product Code
- GGNPlasma, Coagulation Control2Product Code
- GHKCentrifuge, Microsedimentation1Product Code
- GHRReagent, Platelet Aggregation2Product Code
- GIEFibrometer2Product Code
- GKPInstrument, Coagulation, Automated2Product Code
- GKRSystem, Hemoglobin, Automated2Product Code
- GKXInstrument, Automated Platelet Counting2Product Code
- GKZCounter, Differential Cell2Product Code
- K243283Alinity h-series System2Cleared 510(K)
- K240402Cito CBC System2Cleared 510(K)
- K240252UniCel DxH 900 Coulter Cellular Analysis System; UniCel DxH Slidemaker Stainer II Coulter Cellular Analysis System; UniCel DxH 690T Coulter Cellular Analysis System2Cleared 510(K)
- K232946Yumizen H25002Cleared 510(K)
- K240636HemoScreen Hematology Analyzer2Cleared 510(K)
- K230887Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer2Cleared 510(K)
- K230878QScout Lab; QScout RLD2Cleared 510(K)
- K222148HemoScreen Hematology Analyzer2Cleared 510(K)
- K220031Alinity h-series System2Cleared 510(K)
- K210346Sysmex XW-100 Automated Hematology Analyzer2Cleared 510(K)
- K211840Sight OLO2Cleared 510(K)
- K200828Athelas Home2Cleared 510(K)
- K193124Unicel DxH 800 Coulter Cellular Analysis System2Cleared 510(K)
- K190898Sight OLO2Cleared 510(K)
- K182886Cytomics FC 500 Series (MPL or MCL) Flow Cytometer2Cleared 510(K)
- K190294CELL-DYN Emerald 22 AL System2Cleared 510(K)
- K181475DxH 520 Hematology Instrument2Cleared 510(K)
- K182389Sysmex XN-L Automated Hematology Analyzer2Cleared 510(K)
- K181288Athelas One2Cleared 510(K)
- K180020HemoScreen Hematology Analyzer2Cleared 510(K)
- K171655cobas m 511 integrated hematology analyzer2Cleared 510(K)
- K172604XW-100 Automated Hematology Analyzer for CLIA Waived Use2Cleared 510(K)
- K170353ABX MICROS ES 60 OT and ABX MICROS ES 60 CT2Cleared 510(K)
- K162977ADVIA 2120i, ADVIA 21202Cleared 510(K)
- K153538Dextramer CMV Kit2Cleared 510(K)
- K160538Sysmex XN-L Automated Hematology Analyzer2Cleared 510(K)
- K162414UniCel DxH SlideMaker Stainer Coulter Cellular Analysis System2Cleared 510(K)
- K160429BC-5390 Auto Hematology Analyzer2Cleared 510(K)
- K151133PENTRA XLR2Cleared 510(K)
- K143577XW-100 Automated Hematology Analyzer, XW QC CHECK2Cleared 510(K)
- K143348BC-3600 Auto Hematology Analyzer2Cleared 510(K)
- K141161ABX MICROS ES 60 CT; (OPEN TUBE MODEL), (CLOSE TUBE MODEL)2Cleared 510(K)
- K141681SYSMEX XN SERIES2Cleared 510(K)
- K140911UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM/ UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEM2Cleared 510(K)
- K120771UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM2Cleared 510(K)
- K112605SYSMEX XN-SERIES2Cleared 510(K)
- K111534ABACUS 3CP2Cleared 510(K)
- K112755ABACUS 52Cleared 510(K)
- K110381CELL-DYN EMERALD 22 SYSTEM2Cleared 510(K)
- K102644ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120I2Cleared 510(K)
- K102064BD FACS SAMPLE PREP ASSISTANT III (SPA III)2Cleared 510(K)
- K100489DXH 300 COULTER CELLULAR ANALYSIS SYSTEM, DXH 300C COULTER CELLULAR ANALYSSI SYSTEM MODEL: 71772, 717712Cleared 510(K)
- K090346ADVIA 2120/2120I BODY FLUIDS2Cleared 510(K)
- K093394BC-3200 AUTO HEMATOLOGY ANALYZER,M-30D DILUENT, M-30R RINSE, M-30CFL LYSE, M-30E-Z CLEANSER, M-30PROBE CLEANSER, BC-3D C2Cleared 510(K)
- K091313SYSMEX MODEL XT-4000I2Cleared 510(K)
- K090810THERMO SCIENTIFIC CYTO-CAL COUNT TUBES2Cleared 510(K)
- K090967BD MULTITEST 6-COLOR TBNK REAGENT, MODEL 6446112Cleared 510(K)
- K090013CHEMPAQ XBC ANALYZER2Cleared 510(K)
- K082091TRI T-STAT REAGENT ASSAY (DRIED FORM) MODEL 25107-002Cleared 510(K)
- K081495CELL-DYN EMERALD SYSTEM2Cleared 510(K)
- K083420MEDONIC M SERIES2Cleared 510(K)
- K081930UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM2Cleared 510(K)
- K081890SYSMEX XT-SERIES IG PARAMETER,SYSMEX XT-SERIES RET-HE PARAMETER2Cleared 510(K)
- K081610SYSMEX MODEL XS-1000IC AUTOMATED HEMATOLOGY ANALYZER2Cleared 510(K)
- K081526FLOWCARE TLG REAGENT2Cleared 510(K)
- K081213BD FACSCOUNT CD4 REAGENTS WITH MODEL 3390102Cleared 510(K)
- K072869POINTCARE NOW SYSTEM2Cleared 510(K)
- K071562D3 HEMATOLOGY ANALYZER, MODEL D32Cleared 510(K)
- K071967SYSMEX XE-50002Cleared 510(K)
- K071681CYTOMICS FC 500 MPL FLOW CYTOMETER, MODEL # 6265542Cleared 510(K)
- K063407BC-3200 AUTO HEMATOLOGY ANALYZER2Cleared 510(K)
- K071141BD TRITEST CD3/CD4/CD45 WITH BD TRUCOUNT ABSOLUTE COUNT TUBES, MODEL 3404022Cleared 510(K)
- K071143BD TRITEST CD3/CD4/CD45, MODEL 3403832Cleared 510(K)
- K061616COULTER LH 780 HEMATOLOGY ANALYZER2Cleared 510(K)
- K062087BD FACSCANTO II FLOW CYTOMETER, MODEL 338960; (5-3), MODEL 339473; (4-2-2), MODEL 3389622Cleared 510(K)
- K060423CYAN DXD, MULTITEST CD8/CD4/CD3, CD3-FITC, CD3-RPE, CD3-APC AND FLUOROSPHERES2Cleared 510(K)
- K061574COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 66056322Cleared 510(K)
- K061667CELL-DYN RUBY SYSTEM2Cleared 510(K)
- K061150SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XT-SERIES2Cleared 510(K)
- K060375BD MULTITEST 6-COLOR TBNK REAGENT WITH BD TRUCOUNT TUBES WITH MODELS 337 AND 1662Cleared 510(K)
- K060656SYSMEX AUTOMATED HEMATOLOGY ANALYZER MODELS XS SERIES2Cleared 510(K)
- K053497GUAVA EZCD4 SYSTEM2Cleared 510(K)
- K053308ABX MICROS CRP 200, OPTION IM2Cleared 510(K)
- K050758CHEMPAQ XBC ANALYZER2Cleared 510(K)
- K052905MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER2Cleared 510(K)
- K051459SYSMEX MODEL XE-2100DC AUTOMATED HEMATOLOGY ANALYZER2Cleared 510(K)
- K050421MS 4/5 HEMATOLOGY ANALYZER2Cleared 510(K)
- K051199IPF (IMMATURE PLATELET FRACTION) PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER2Cleared 510(K)
- K051122ITAG MHC TETRAMER CMV ASSAY2Cleared 510(K)
- K050436MS 9/5 HEMATOLOGY ANALYZER2Cleared 510(K)
- K051215CELL-DYN SAPPHIRE SYSTEM2Cleared 510(K)
- K050589RET-HE PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER2Cleared 510(K)
- K050719ABX PENTRA DX 120: OPTION SPS EVOLUTION2Cleared 510(K)
- K050057COULTER LH 750 HEMATOLOGY ANALYZER2Cleared 510(K)
- K043215FLOWCARE PLG CD4 REAGENT2Cleared 510(K)
- K041882FLOWCARE SYSTEM2Cleared 510(K)
- K042724MODIFICATION TO COULTER LH 500 HEMATOLOGY ANALYZER2Cleared 510(K)
- K042173COULTER A T 5DIFF CAP PIERCE (CP)2Cleared 510(K)
- K042251BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM2Cleared 510(K)
- K041074BD FACSCANTO WITH BD FACSANTO SOFTWARE2Cleared 510(K)
- K040725BD FACSCANTO SYSTEM2Cleared 510(K)
- K040026BD FACS 7-COLOR SETUP BEADS2Cleared 510(K)
- K040073SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XE-2100 SERIES (XE-2100, XE-2100L)2Cleared 510(K)
- K032214MEDONIC CA620/530 HEMATOLOGY ANALYZER2Cleared 510(K)
- K030263IMMUNICON CELLTRACKS ANALYZER2Cleared 510(K)
- K032342COULTER LH 750 HEMATOLOGY ANALYZER2Cleared 510(K)
- K032524ADVIA 60 HEMATOLOGY ANALYZER2Cleared 510(K)
- K032039IMMATURE GRANULOCYTE (IG) PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER2Cleared 510(K)
- K032000COULTER LH 500 HEMATOLOGY ANALYZER2Cleared 510(K)
- K032013COULTER ACT 5DIFF AL HEMATOLOGY ANALYZER2Cleared 510(K)
- K030828TETRACXP SYSTEM (SOFTWARE AND SYSTEM GUIDE)2Cleared 510(K)
- K030513CELL-DYN 1800 SYSTEM2Cleared 510(K)
- K030606COULTER LH 750 BODY FLUIDS APPLICATION2Cleared 510(K)
- K030291COULTER ACT 5DIFF AUTOLOADER (AL)2Cleared 510(K)
- K030799MICROS 602Cleared 510(K)
- K030408CYTO-STAT TETRACHROME CD45-FIT/CD4-PE/CD3-PC5 MONOCLONAL ANTIBODY REAGENT, CYTO-STAT TETRACHROM CD45-FITC/CD56-PE/CD19-A2Cleared 510(K)
- K030144MODIFICATION TO PENTRA 60 AND PENTRA 60C+2Cleared 510(K)
- K024002PENTRA 802Cleared 510(K)
- K022668ADVIA 120 HEMATOLOGY SYSTEM COMPLETE BLOOD COUNT (CBC) METHOD2Cleared 510(K)
- K022528IQ PRODUCTS TRIPLE-COLOR FLOW CYTOMETRY REAGENTS, IQ PRODUCTS CD45-FITC/CD4-PE/CD3-CYQ, IQ PRODUCTS CD45-FITC/CD8-PE/CDQ2Cleared 510(K)
- K022200PENTRA 120/PENTRA 120 RETIC OPTIONS SPS, MODEL PENTRA 1202Cleared 510(K)
- K022161MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 66056322Cleared 510(K)
- K021241SYSMEX XT-SERIES, MODEL XT-2000I AND XT-1800I2Cleared 510(K)
- K020496HPC (HEMATOPOIETIC PROGENITOR CELL) PARAMETER ON THE IMI CHANNEL OF THE SYSMEX SE-9500 AND XE-2100, AUTOMATED HEMATOLOGY2Cleared 510(K)
- K012934CELL-DYN 3200 SYSTEM WITH ABSOLUTE AND PERCENT RETICULOCYTE2Cleared 510(K)
- K012904ADVIA 120 HEMATOLOGY SYSTEM, CYANIDE-FREE HIGH DETERMINATION2Cleared 510(K)
- K011342COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 66056322Cleared 510(K)
- K010953CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAY2Cleared 510(K)
- K010765COULTER HMX ANALYZER, MODEL 6605523, COULTER HMX WITH AUTOLOADER, MODEL 66055262Cleared 510(K)
- K003796ADVIA 120 HEMATOLOGY2Cleared 510(K)
- K003677ABX PENTRA 60C+ HEMATOLOGY ANALYZER2Cleared 510(K)
- K002646ABX MICROS CRP2Cleared 510(K)
- K000611STELLER CD61 ASSAY FOR USE ON THE IMAGN 2000 MICROVOLUME FLUORIMETER2Cleared 510(K)
- K000897CALIBRITE PERCP-CY5.5 BEADS AND FACSCOMP SOFTWARE2Cleared 510(K)
- K993356COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSES2Cleared 510(K)
- K992875SYSMEX XE-2100, AUTOMATATED HEMATOLOGY ANALYZER2Cleared 510(K)
- K992511ABX PENTRA 60 HEMATOLOGY ANALYZER2Cleared 510(K)
- K992444MODIFICATION OF: CELL-DYN 1200 SYSTEM2Cleared 510(K)
- K992849QBC STAR CENTRIFUGAL HEMATOLOGY SYSTEM2Cleared 510(K)
- K991839ABX PENTRA 120 RETIC AUTOMATED HEMATOLOGY ANALYZER2Cleared 510(K)
- K991605CELL-DYN 3500 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION (IRF), CELL-DYN 3700 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION2Cleared 510(K)
- K991539EXCELL 222Cleared 510(K)
- K991142CELL-DYN 1200 SYSTEM2Cleared 510(K)
- K991454MOUSE IGG1 NEGATIVE CONTROLS2Cleared 510(K)
- K991402DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE-CY5, CLONE UCHT1 & DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE, CLONE UCHT12Cleared 510(K)
- K990327RETICONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS2Cleared 510(K)
- K990172TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS WITH CYTO-STAT TETRACHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 MONOCLA2Cleared 510(K)
- K990352COULTER AC T DIFF 2 ANALYZER2Cleared 510(K)
- K990311VEGA RETIC AUTOMATED HEMATOLOGY ANALYZER2Cleared 510(K)
- K982167CYTO-STAT TRICHROME CD45-FITC/CD19-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD12Cleared 510(K)
- K982166CYTO-STAT TRICHROME CD45-FITC/CD56-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME CD45-FITC/MSIGG1-RD12Cleared 510(K)
- K983562MASCOT MD HEMATOLOGY ANALYZER/ MODEL MD 7002Cleared 510(K)
- K982172CYTO-STAT CD3-FITC/CD56-RDI MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT/COULTER CLONE MSIGGI-RD1/MSIGGI-FITC ISOTYPIC COL2Cleared 510(K)
- K982802BAYER ADVIA 60 HEMATOLOGY SYSTEM (IN VITRO DIAGNOSTIC SYSTEM)2Cleared 510(K)
- K981568MASCOT MD HEMATOLOGY ANALYZER, MODEL MD 8002Cleared 510(K)
- K980635DAKO MOUSE ANTI-HUMAN B-CELL, CD19/RPE-CY5, CLONE HD372Cleared 510(K)
- K982231STATUSFLOW2Cleared 510(K)
- K981342ABBOTT CELL-DYN 4000 IMMUNOPIT (CD61) ASSAY2Cleared 510(K)
- K980858MULTITEST CD3/CD16+56/CD45/CD19 REAGENT AND MULTITEST IMK KIT LYSING SOLUTION2Cleared 510(K)
- K980614ABBOTT CELL-DYN 3000 SERIES HEMATOLOGY SYSTEMS2Cleared 510(K)
- K974360MULTITEST CD3/CD8/CD45/CD42Cleared 510(K)
- K973483FACSCOMP SOFTWARE AND CALIBRITE BEADS FOR USE IN FLOW CYTOMETER INSTRUMENT SET2Cleared 510(K)
- K971205TRI TEST REAGENT CD4 FIT C/CD8 PE/CD3 PERCP WITH TRUCOUNT ABSOLUTE COUNT TUBES2Cleared 510(K)
- K971110TRITEST REAGENT CD3 FITC/CD16+CD56 PE/CD45 PERCP;WITH TRUCOUNT ABSOLUTE COUNT TUBES2Cleared 510(K)
- K970326TRITEST REAGENT CD3 FITC/CD8 PE/CD45 PERCP;WITH TRUCOUNT ABSOLUTE COUNT TUBES2Cleared 510(K)
- K965053TRITEST REAGENT CD3 FITC/CD4 PE/CD45 PERCP; TRUCOUNT ABSOLUTE COUNT TUBES2Cleared 510(K)
- K973634COULTER AC.T DIFF ANALYZER2Cleared 510(K)
- K970742TRITEST CD3 FITC/CD19 PE/CD45 PERCP REAGENT WITH TRUCOUNT ABSOLUTE COUNT TUBES2Cleared 510(K)
- K972354ABBOTT CELL-DYN 3200 SYSTEM2Cleared 510(K)
- K971736SYSMEX IMMATURE RETICULOCYTE FRACTION (IRF) PARAMETER2Cleared 510(K)
- K970836TRUCOUNT ABSOLUTE COUNT TUBES/COUNTING CONTROL BEADS2Cleared 510(K)
- K971152ABBOTT CELL-DYN 4000 IMMATURE RETICULOCYTE FRACTION (IRF)2Cleared 510(K)
- K951459ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATE2Cleared 510(K)
- K964974MOUSE ANTI-HUMAN CD45, LEUCOCYTE COMMON ANTIGEN (LCA)/FITC AND CD14, MONOCYTE/RPE2Cleared 510(K)
- K965232CALTAG CAL-LYSE2Cleared 510(K)
- K964988COULTER AC.T SERIES ANALYZER2Cleared 510(K)
- K960072SPIRIT HEMATOLOGY SYSTEM MODEL LE, CP, & AX2Cleared 510(K)
- K951632ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE)2Cleared 510(K)
- K964754ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATE2Cleared 510(K)
- K963263TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS AND CYTO-STAT TERTRACHROME CD45-FITC/CD4-RDI/CD8-ECD/CD3-PC52Cleared 510(K)
- K964856CD3 FITC/CD19 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION2Cleared 510(K)
- K962768CYTO-STAT TRICHROME CD45-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANITBODY REAGENT W/ISOTYPIC CONTROL2Cleared 510(K)
- K962305CYTO-STAT TRICHROME CD45-FITC/CD8-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT IWTH ISOTYPIC CONTROL2Cleared 510(K)
- K964618CYTO-STAT TRICHROME CD8-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME MSIGGI-FITC/MSIGGI-RD12Cleared 510(K)
- K963963MULTISET SOFTWARE FOR AUTOMATED FLOW CYTOMETRIC DATA ANALYSIS2Cleared 510(K)
- K963954CD 19 R-PE, CD19 TRI-COLOR MONOCLONAL ANTIBODY2Cleared 510(K)
- K962633VEGA HEMATOLOGY ANALYZER2Cleared 510(K)
- K961439ABBOTT CELL-DYN 4000 SYSTEM2Cleared 510(K)
- K955715CELL DYN 3500 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER (MODIFICATION)2Cleared 510(K)
- K954594RETICULOCYTE METHOD, RBC INDICES2Cleared 510(K)
- K961278COULTER STKS ANALYZER WITH CD4 & CD8 LYMPHOCYTE ANALYSIS2Cleared 510(K)
- K961701MOUSE ANTI-HUMAN CD3, T-CELL, FITC AND CD4, T-CELL, (HELPER/INDUCER) RPE2Cleared 510(K)
- K961610R & D SYSTEMS' WHOLE BLOOD FLOW CONTROL, (R & D - WBFC)2Cleared 510(K)
- K961435MOUSE ANTI-HUMAN CD2, T-CELL/FITC AND MOUSE ANTI-HUMAN CD19, B-CELL/RPE2Cleared 510(K)
- K960531MOUSE ANTI-HUMAN CD3, T-CELL/FITC & CD19, B-CELL/RPE2Cleared 510(K)
- K961623FACSCOMP SOFTWARE & CALIBRITE 3 COLOR BEADS KIT/CALIBRITE PERCP BEADS2Cleared 510(K)
- K942525MEDICOUNT DEKA HEMATOLOGY ANALYZER2Cleared 510(K)
- K955673CELL DYN 3000 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER (MODIFICATION)2Cleared 510(K)
- K960887MOUSE ANTI-HUMAN CD4, T-CELL, HELPER/INDUCER/FITC & CD8, T-CELL, SUPPRESSOR/CYTOTOXIC/RPE2Cleared 510(K)
- K960827QBC ACCUTUBE(423406)/QBC AUTOREAD(424571)2Cleared 510(K)
- K953116WHITE IRIS LEUKOCYTE DIFFERENTIAL ANALYZER2Cleared 510(K)
- K951100ORTHO-MUNE OK-COMBO CD3-FITC/CD19-PE (OKT3/OKB19A MONOLCLONAL ANTIBODY (MURINE)2Cleared 510(K)
- K950625ORTHO-MUNE OK-COMBO CD40FITC/CD8-PE (OKT4A/OKT8) MONOCLONAL ANTIBODY (MURINE)2Cleared 510(K)
- K950568ORTHO-MUNE OK-COMBO CD3-FITC/CD4-PE (OKT2/OKT4A) MONOCLONAL ANTIBODY (MURINE)2Cleared 510(K)
- K950482ORTHO-MUNE OK-COMVO CD3-FITC/CD8-PE (OKT 3/OKT8) MONOCLONAL ANTIBODY (MURINE)2Cleared 510(K)
- K935720ORTHO COUNT CALIBRATION KIT FOR ORTHO CYTORONABSOLUTE LASER FLOW CYTOMETRY SYSTEM2Cleared 510(K)
- K960427ABBOTT CELL-DYN 3500R SYSTEM2Cleared 510(K)
- K954570ORTHO IMMUNOCOUNT FLOW CYTOMETRY SYSTEM2Cleared 510(K)
- K955909MOUSE ANTI-HUMAN CD3, T-CELL, FITC & CD8, T-CELL(SUPPRESSOR/CYTOTOXIC) RPE2Cleared 510(K)
- K953643HEMATIL 18 (H-18)2Cleared 510(K)
- K953598SERIES 9100 PLUS AUTOMATED DIFFERENTIAL HEMATOLOGY ANALYZERS2Cleared 510(K)
- K954688FLOW-COUNT COULTER FLUOROSPHERES2Cleared 510(K)
- K950342TRITEST REAGENT CD3 FITC/CD19 PE/CD45 PERCP2Cleared 510(K)
- K946055TRITEST REAGENT CD3 FITC/CD4 PE/CD45 PERCP2Cleared 510(K)
- K955504QBC ACCUREAD SYSTEM2Cleared 510(K)
- K945212MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD4, CLONE MT310, FITC-CONJUGATED, (ANTI-CD4/FITC, MT310) RPE-CONJUGATED, (ANTI-CD4/2Cleared 510(K)
- K951073CD3 TRI-COLOR/CD4 R-PE/CD8 FITC MONOCLONAL ANTIBODY COMBINATION2Cleared 510(K)
- K950918CD3 FITC/CD4 R-PE MONOCLONAL ANTIBODY COMBINATION2Cleared 510(K)
- K950916CD3 FITC/CD8 R-PE MONOCLONAL ANTIBODY COMBINATION2Cleared 510(K)
- K950917CD3 FITC/CD8 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION2Cleared 510(K)
- K950919CD3 FITC/CD4 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION2Cleared 510(K)
- K945756IMAGN(TM) 2000 SYSTEM2Cleared 510(K)
- K953302FACS LOADER SYSTEM2Cleared 510(K)
- K933878ZYMMUNE(TM) CD4/CD8 CELL MONITORING KIT2Cleared 510(K)
- K954188OPTICLONE IGG1 FITC/IGG2A PE ISOTYPIC CONTROL2Cleared 510(K)
- K946335OPTICLONE(TM CD3 FITC/CD19 PE MONOCLONAL ANTIBODIES2Cleared 510(K)
- K951496CELL-DYN 3500 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER2Cleared 510(K)
- K940003VOLUMET CD4 + AND CD8 + T LYMPHOCYTE COUNT TEST KIT2Cleared 510(K)
- K953448ROCHE COBAS MICROS HEMATOLOGY ANALYZER2Cleared 510(K)
- K953340QBC ACCUTUBE2Cleared 510(K)
- K945205QBC ACCUTUBE2Cleared 510(K)
- K945678DATACELL 18MS2Cleared 510(K)
- K953498OPTICLONE IGG1 FITC/IGG1 PE ISOTYPIC CONTROL2Cleared 510(K)
- K950742CYTO-STAT/COULTER CLONE CD3-ECD/T4-RD1/T8-FITC MONOCLONAL ANTIBOEY REAGENT2Cleared 510(K)
- K950057TRITEST CONTROL REAGENT IGG1 FITC/IGFG1 PE/CD45 PERCP2Cleared 510(K)
- K952789OPTICLONE CD4FITC/CD8 PE MONOCLONAL ANTIBODIES2Cleared 510(K)
- K950949COULTER MH025A2Cleared 510(K)
- K952182OPTICLONE CD3/CD8 MONOCLONAL ANTIBODIES2Cleared 510(K)
- K944127CALTAG CD3 FITC, R-PE, TRI-COLOR MONOCLONAL ANTIBODY2Cleared 510(K)
- K944128CALTAG CD4 R-PE MONOCLONAL ANTIBODY2Cleared 510(K)
- K944126CALTAG CD8 FITC AND CD8 R-PE MONOCLONAL ANTIBODIES2Cleared 510(K)
- K945837SYSMEX(TM) F-820, 5202Cleared 510(K)
- K925255TRAX(TM) CD4 TEST KIT2Cleared 510(K)
- K950626OPTICLONE CD3/CD4 MONOCLONAL ANTIBODIES2Cleared 510(K)
- K941713ORTHO-MUNE 0KT 11 (CD2) MONOCLONAL ANTIBODY (MURINE)2Cleared 510(K)
- K932532ORTHO-MUNE OKT8 (CD8) MONOCLONAL ANTIBODY (MURINE)2Cleared 510(K)
- K932530ORTHO-MUNE OKT 3 MONOCLONAL ANTIBODY (MURINE)2Cleared 510(K)
- K932531ORTHO-MUNE OKT 4 (CD4) MONOCLONAL ANTIBODY MURINE2Cleared 510(K)
- K943967ONYX2Cleared 510(K)
- K943894SYSMEX K-45002Cleared 510(K)
- K945692MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD2, CLONE MT910 FITC-CONJUGATED, (ANTI-CD2,FITC, MT910)2Cleared 510(K)
- K941171TECHNICON H* 3 RTC SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)2Cleared 510(K)
- K944253MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD8, RPE-CONJUGATED, CLONE DK252Cleared 510(K)
- K943284MONOCLONAL MOUSE ANTI-HUMAN B-CELL2Cleared 510(K)
- K942797MONOCLONAL MOUSE ANTI-HUMAN T-CELL2Cleared 510(K)
- K925909GENESIS 1, AUTOMATED CELL COUNTER, MODIFICATION2Cleared 510(K)
- K925274AUTOCOMP(TM) SOFTWARE AND CALIBRITE(TM) BEADS2Cleared 510(K)
- K933486FASCOUNT SYSTME2Cleared 510(K)
- K936023SYSMEX SE-9000 AUTOMATED HEMATOLOGY ANALYZER2Cleared 510(K)
- K933475TECHNICON H* 2 SYSTEM, LABFACTS SOFTWARE FOR U.I.W. VERSIONS 4.11 & 5.112Cleared 510(K)
- K933478TECHNICON H*1 SYSTEMS, LABFACTS SOFTWARE FOR U.I.W. VERSIONS 4.11 & 5.112Cleared 510(K)
- K923790FACSORT FLOW CYTOMETER2Cleared 510(K)
- K932030COULTER STKS WITH RETICULOCYTE ANALYSIS CAPABILITY2Cleared 510(K)
- K930913COULTER MH015 (DIFFERENTIAL CELL COUNTER)2Cleared 510(K)
- K924587SIMULTEST CD3/ANTI-HLA-DR2Cleared 510(K)
- K930309ABBOTT ENCOUNTER(TM)Q2Cleared 510(K)
- K926124CYTO-STAT/COULTER CLONE CD3 (IGG1)-FITC/B4-RD1 MON2Cleared 510(K)
- K930148TECHNICON H* 3 RTX SYSTEM (IN-VITRO DIAG. SYSTEM)2Cleared 510(K)
- K925528BIOVATION K-MANAGER2Cleared 510(K)
- K923773CELLEXIS HEMATOLOGY ANALYZER2Cleared 510(K)
- K922745CYTO-STAT/COULTER CLONE CD3(IGG1)-FITC/T4-RD12Cleared 510(K)
- K922744CYTO-STAT/COULTER CLONE CD 3(IGG1)-FITC/T8-RD12Cleared 510(K)
- K925344COULTER NEW METH BLUE PREPREP RETIC/MAXM W/AUTOLOA2Cleared 510(K)
- K921279CD4 CYTOSPHERES KIT2Cleared 510(K)
- K923237TECHNICON H*22Cleared 510(K)
- K922181COULTER MH0092Cleared 510(K)
- K922085MONOCLONAL ANTIBODY IGG2A ISOTYPE CONT. FLOW CYTOM2Cleared 510(K)
- K922084MONOMCLONAL ANTIBODY IGG1 ISOTYPE CONT. FLOW CYTOM2Cleared 510(K)
- K922704COULTER MAXM W/ AUTOLOADER2Cleared 510(K)
- K921567COULTER MH0172Cleared 510(K)
- K914846CD2 MONOCLONAL ANTIBODIES2Cleared 510(K)
- K914848CD4 MONOCLONAL ANTIBODIES2Cleared 510(K)
- K920949SOFTWARE MODIFICATION FOR MILES H*1 S/W VER. 1.52Cleared 510(K)
- K920544SYSMEX HEMATOLOGY SYSTEM ACCESSORIES2Cleared 510(K)
- K913192SIMULTEST(TM) IMK-LYMPHOCYTE2Cleared 510(K)
- K915071DIFFERENTIAL COUNTING BOARD2Cleared 510(K)
- K914744SYSMEX NE-1500, MODIFICATION2Cleared 510(K)
- K914014FACSTRAK FLOW CYTOMETER2Cleared 510(K)
- K913305CELL-DYN 3000A MULTI-PARAMETER AUTO HEMA ANALZYER2Cleared 510(K)
- K910473CYTO-STAT(R)/COULTER CLONE(R) T11-RD1/B4-FITC2Cleared 510(K)
- K901187MONOCLONAL ANTIBODY ANTI-CD22Cleared 510(K)
- K901186MONOCLONAL ANTIBODY ANTI-CD192Cleared 510(K)
- K901189MONOCLONAL ANTIBODY ANTI-CD32Cleared 510(K)
- K901188MONOCLONAL ANTIBODY ANTI-CD52Cleared 510(K)
- K913259NOVA CELLTRAK 12 AUTO MULTI-PARA HEMA ANALYZER/CAL2Cleared 510(K)
- K911626SYSTEM 9000, INTERPRETIVE DIFF CELL COUNTER2Cleared 510(K)
- K911793COULTERCLONE2Cleared 510(K)
- K911385COULTER(R) MH0102Cleared 510(K)
- K904253ORTHO MUNE OKT3,4, AND 8 MONOCLONAL ANTIBODY2Cleared 510(K)
- K910834QBC AUTOREADER2Cleared 510(K)
- K910283DANAM DATACELL-182Cleared 510(K)
- K904390ANTI-HUMAN LEU-2A (CD8) PE2Cleared 510(K)
- K904209SIMULTEST T & B CELL TEST,ANTI-LEU-4 FITC & 12 PE2Cleared 510(K)
- K903665CELL-DYN 1400 MULTI-PARAMETER AUTOMATED HEMATOLOGY2Cleared 510(K)
- K900802ANTI-HUMAN LEU-3A (CD4) FITC2Cleared 510(K)
- K900684RDW AND MPV INDICES ON HEMAT 122Cleared 510(K)
- K900276EXACT ONE(TM) HEMATOLOGY ANALYZER2Cleared 510(K)
- K900078SIMULTEST IMK PLUS(TM)2Cleared 510(K)
- K896873COULTER JT32Cleared 510(K)
- K900593TECHNICON H*2(TM) SYSTEM2Cleared 510(K)
- K893852COULTER CLONE T4 MONOCLONAL ANTIBODY2Cleared 510(K)
- K893853COULTER CLONE T8 MONOCLONAL ANTIBODY2Cleared 510(K)
- K894179COULTER CLONE(R) MY4 MONOCLONAL ANTIBODY2Cleared 510(K)
- K895917CYTO-STAT/COULTER CLONE T4-RD1/T8-FITC MONO ANTI2Cleared 510(K)
- K890349SIMULTEST IMK FOR FACS ANALYZER OR FACSCAN2Cleared 510(K)
- K895127ARGOS2Cleared 510(K)
- K884605COULTER CLONE MO22Cleared 510(K)
- K891276QBC MALARIA SYSTEM2Cleared 510(K)
- K893423QBC III CENTRIFUGAL HEMATOLOGY SYSTEM2Cleared 510(K)
- K892205DANAM VECTOR-8+2Cleared 510(K)
- K890491CELL-DYN 3000 MULTI-PARAMETER HEMATOLOGY ANALYER2Cleared 510(K)
- K885028COULTER 5P CONTROL2Cleared 510(K)
- K884020COULTER CLONE B4 MONOCLONAL ANTIBODY2Cleared 510(K)
- K883753COULTER CLONE T1 MONOCLONAL ANTIBODY2Cleared 510(K)
- K883710COULTER CLONE T3 MONOCLONAL ANTIBODY2Cleared 510(K)
- K885093COULTER STKS2Cleared 510(K)
- K884346CYTO-STAT/COULTER CLONE T11-RD1/B1-FITC MONO. ANTI2Cleared 510(K)
- K884006HEMAT 122Cleared 510(K)
- K883997SYSMEX NE-80002Cleared 510(K)
- K883177H 10 OR HEMATIL 10 BLOOD CELL & PLATELET COUNTER2Cleared 510(K)
- K882557COULTER CLONE B1 MONOCLONAL ANTIBODY2Cleared 510(K)
- K882612SYSTEM 9000 DIFF MODEL AUTOMATED CELL COUNTER2Cleared 510(K)
- K882579HEMATRAK(R) MODEL 5902Cleared 510(K)
- K882370SYSMEX K-1000 18 PARAMETER, AUTO. HEMA ANALYZER2Cleared 510(K)
- K880616MINOS AUTOMATIC CELL COUNTER2Cleared 510(K)
- K875346AUTOLYZER 801 SYSTEM (AUTOMATED CELL COUNTER)2Cleared 510(K)
- K880507COULTER VCS LEUKOCYTE DIFFERENTIAL COUNTER2Cleared 510(K)
- K875047COULTER CLONE T11 MONOCLONAL ANTIBODY2Cleared 510(K)
- K874838COULTER COUNTER MODEL T SERIES W/2-PART DIFFERENT.2Cleared 510(K)
- K874763CELLECT MODEL D, AUTOMATED HEMTALOGY ANALYZER2Cleared 510(K)
- K874147QBC BLOOD BANK SYSTEM2Cleared 510(K)
- K874427QBC SYSTEM HEMOGLOBIN2Cleared 510(K)
- K873734SYSMEX F-800 15 PARAMETER, SEMI-AUTO HEMA ANALYZER2Cleared 510(K)
- K873256MICRO-COUNT DIFFHE2Cleared 510(K)
- K872761CELL-DYN 610 HEMATOLOGY ANALYZER2Cleared 510(K)
- K864579MINOS AUTOMATIC CELL COUNTER2Cleared 510(K)
- K871837COULTER COUNTER MODEL S-PLUS STKR2Cleared 510(K)
- K871600SYSMEX M-2000 18-PARAMETER, FULLY AUTO HEMA ANALY.2Cleared 510(K)
- K870233CELL-DYN 1600 MULTIPARAMETER AUTO. HEMA. ANALYZER2Cleared 510(K)
- K855116SYSMEX E-5000 FULLY AUTOMATED HEMATOLOGY SYSTEM2Cleared 510(K)
- K855117SYSMEX E-2500 AUTOMATED HEMATOLOGY SYSTEM2Cleared 510(K)
- K853027TECHNICON H*1 SYSTEM (MPXI)2Cleared 510(K)
- K853029TECHNICON H*1 SYSTEM LOBULARITY INDX/LFT SHIFT FLA2Cleared 510(K)
- K852988TECHNICON H*1 SYSTEM SUB-CLASSIFICATION LUC CAT.2Cleared 510(K)
- K854368CELL-DYN 1500 MULTI-PARAMETER HEMATOLOGY ANALYZER2Cleared 510(K)
- K854242QBC CENTRIFUGAL HEMATOLOGY SYSTEM2Cleared 510(K)
- K85330421 HEMATOLOGY REAGENTS2Cleared 510(K)
- K852371CELL-DYN 2000 AUTOMATED MULTI-PARAMETER HEMATOLOGY2Cleared 510(K)
- K850354SYSMEX E-5000, FULLY AUTOMATED HEMATOLOGY SYS2Cleared 510(K)
- K844910SYSMEX CC-800/PDA-410 W/TRI-MODAL LEUKOCYTE SIZE -2Cleared 510(K)
- K844645QBC CENTRIFUGAL HEMATOLOGY ANALYZER2Cleared 510(K)
- K841852AUTOLYZER 8002Cleared 510(K)
- K842636TECHNICON H*1 SYSTEM2Cleared 510(K)
- K840195FACS ANALYZER2Cleared 510(K)
- K833618ORTHO ELT-8/DS HEMATOLOGY ANALYZER2Cleared 510(K)
- K833600COULTER COUNTER MODEL S-PLUS V2Cleared 510(K)
- K831271ELT-8/DS HEMATOLOGY ANALYZER & LYSRIG2Cleared 510(K)
- K823355COULTER-COUNTER #S PLUS IV & LYSE S +D2Cleared 510(K)
- K821186PENETRAK TM2Cleared 510(K)
- K803219ADC-500 AUTOMATED DIFFER. CELL CNTR. SY.2Cleared 510(K)
- K800533ADD OF RETICULOCYTE COUNT/CAPABILITIES2Cleared 510(K)
- K800121TECHNICON C/90 SYSTEM2Cleared 510(K)
- K791903COULTER DIFF3 SYS. (COULTER #7400003)2Cleared 510(K)
- K791041HEMATRAK ABNORMAL RECOGNITION2Cleared 510(K)
- K791108CONTEXT FILTER2Cleared 510(K)
- K790816HEMATRAK MODEL 4802Cleared 510(K)
- K782050PRINTER, TEK PRO TEK TALLY II2Cleared 510(K)
- K780577PLATELETS/CU MM2Cleared 510(K)
- K761207HEMATRAK RBC MORPHOLOGY2Cleared 510(K)
- K770244AUTO DIFFERENTIAL CELL COUNTER SYSTEM2Cleared 510(K)
- K770680HEMATRAK2Cleared 510(K)
- K770550ATYPIA PROFILE MONITOR2Cleared 510(K)
- K770701HEMATRAK MODEL 1252Cleared 510(K)
- K770869ATYPICAL LYMPHOCYTE & NCB CLASSIFICATION2Cleared 510(K)
- K761208HEMATRAK MATURITY PROFILE OPTION2Cleared 510(K)
- JBTTimer, Coagulation2Product Code
- JBWRed-Cell Indices, Measured2Product Code
- JOXAnalyzer, Heparin, Automated2Product Code
- JOYDevice, Automated Cell-Locating2Product Code
- JOZSystem, Automated Platelet Aggregation2Product Code
- JPASystem, Multipurpose For In Vitro Coagulation Studies2Product Code
- JPJRed-Cell Indices, Calculated2Product Code
- JWODevice, Blood Volume Measuring2Product Code
- KQGInstrument, Coagulation2Product Code
- KQHRed-Cell Indices2Product Code
- LGPAssay, Alpha-2-Antiplasmin2Product Code
- LKMCounter, Urine Particle2Product Code
- LLGKit, Igg, Platelet Associated2Product Code
- MAMDna-Probe, B And T Lymphocyte2Product Code
- OBW11-Dehydro Thromboxane B2 Kit, Urinary2Product Code
- OYEFlow Cytometric Reagents And Accessories.2Product Code
- PMGAutomated Multicolor Fluorescent Imaging Cytometric Analysis System2Product Code
- POVSemen Analysis Device2Product Code
- QFRCoagulation System For The Measurement Of Whole Blood Viscoelastic Properties2Product Code
- Subpart F—General Hospital and Personal Use Therapeutic DevicesCFR Sub-Part
- Subpart F—Immunological Test SystemsCFR Sub-Part
- Subpart G—Manual Hematology DevicesCFR Sub-Part
- Subpart G—Tumor Associated Antigen immunological Test SystemsCFR Sub-Part
- Subpart H—Hematology Kits and PackagesCFR Sub-Part
- Subpart I—Hematology ReagentsCFR Sub-Part
- Subpart J—Products Used In Establishments That Manufacture Blood and Blood ProductsCFR Sub-Part
- Subpart K—Products Used In Establishments That Manufacture Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)CFR Sub-Part
- ImmunologyReview Panel
- MicrobiologyReview Panel
- NeurologyReview Panel
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
- OrthopedicReview Panel
- PathologyReview Panel
- Physical MedicineReview Panel
- RadiologyReview Panel
- General and Plastic SurgeryReview Panel
- ToxicologyReview Panel
- Medical GeneticsReview Panel
- UnknownReview Panel
XW-100 Automated Hematology Analyzer for CLIA Waived Use
- Page Type
- Cleared 510(K)
- FDA Hosted PDF* The FDA doesn't provide PDFs for all submissions.
- 510(k) Number
- K172604
- 510(k) Type
- Dual Track
- Applicant
- Sysmex America, Inc.
- Country
- United States
- FDA Decision
- Substantially Equivalent
- Decision Date
- 11/6/2017
- Days to Decision
- 68 days
- Submission Type
- Summary