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GKZ

380 FDA 510(k) clearances · Product code

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RecordFirmDate
ORTHO COUNT CALIBRATION KIT FOR ORTHO CYTORONABSOLUTE LASER FLOW CYTOMETRY SYSTEM (K935720)Ortho Diagnostic Systems, Inc.1996-05-09
ABBOTT CELL-DYN 3500R SYSTEM (K960427)Sequoia Turner Corp.1996-05-02
ORTHO IMMUNOCOUNT FLOW CYTOMETRY SYSTEM (K954570)Ortho Diagnostic Systems, Inc.1996-04-30
MOUSE ANTI-HUMAN CD3, T-CELL, FITC & CD8, T-CELL(SUPPRESSOR/CYTOTOXIC) RPE (K955909)Dako Corp.1996-03-28
HEMATIL 18 (H-18) (K953643)Texas Intl. Laboratories, Inc.1996-03-22
SERIES 9100 PLUS AUTOMATED DIFFERENTIAL HEMATOLOGY ANALYZERS (K953598)Serono Diagnostics, Inc.1996-03-11
FLOW-COUNT COULTER FLUOROSPHERES (K954688)Coulter Corp.1996-02-29
TRITEST REAGENT CD3 FITC/CD4 PE/CD45 PERCP (K946055)Becton Dickinson Immunocytometry Systems1996-02-20
TRITEST REAGENT CD3 FITC/CD19 PE/CD45 PERCP (K950342)Becton Dickinson Immunocytometry Systems1996-02-20
QBC ACCUREAD SYSTEM (K955504)Becton Dickinson Diagnostic Instrument Systems1996-02-05
MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD4, CLONE MT310, FITC-CONJUGATED, (ANTI-CD4/FITC, MT310) RPE-CONJUGATED, (ANTI-CD4/ (K945212)Dako Corp.1996-01-26
CD3 FITC/CD8 R-PE MONOCLONAL ANTIBODY COMBINATION (K950916)Caltag Laboratories, Inc.1995-12-21
CD3 FITC/CD4 R-PE MONOCLONAL ANTIBODY COMBINATION (K950918)Caltag Laboratories, Inc.1995-12-21
CD3 FITC/CD8 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION (K950917)Caltag Laboratories, Inc.1995-12-21
CD3 TRI-COLOR/CD4 R-PE/CD8 FITC MONOCLONAL ANTIBODY COMBINATION (K951073)Caltag Laboratories, Inc.1995-12-21
CD3 FITC/CD4 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION (K950919)Caltag Laboratories, Inc.1995-12-20
IMAGN(TM) 2000 SYSTEM (K945756)Buckman Co., Inc.1995-12-19
FACS LOADER SYSTEM (K953302)Becton Dickinson Immunocytometry Systems1995-11-20
ZYMMUNE(TM) CD4/CD8 CELL MONITORING KIT (K933878)Intracel Corp.1995-11-14
OPTICLONE IGG1 FITC/IGG2A PE ISOTYPIC CONTROL (K954188)Immunotech Corp.1995-11-03
OPTICLONE(TM CD3 FITC/CD19 PE MONOCLONAL ANTIBODIES (K946335)Immunotech, Inc.1995-10-20
VOLUMET CD4 + AND CD8 + T LYMPHOCYTE COUNT TEST KIT (K940003)Buckman Co., Inc.1995-10-19
CELL-DYN 3500 MULTI-PARAMETER AUTOMATED HEMATOLOGY ANALYZER (K951496)Abbott Laboratories1995-10-19
ROCHE COBAS MICROS HEMATOLOGY ANALYZER (K953448)Roche Diagnostic Systems, Inc.1995-10-13
QBC ACCUTUBE (K953340)Becton Dickinson Diagnostic Instrument Systems1995-10-05
QBC ACCUTUBE (K945205)Becton Dickinson Diagnostic Instrument Systems1995-09-25
DATACELL 18MS (K945678)Danam Electronics1995-09-12
OPTICLONE IGG1 FITC/IGG1 PE ISOTYPIC CONTROL (K953498)Immunotech, Inc.1995-09-08
CYTO-STAT/COULTER CLONE CD3-ECD/T4-RD1/T8-FITC MONOCLONAL ANTIBOEY REAGENT (K950742)Coulter Corp.1995-08-25
TRITEST CONTROL REAGENT IGG1 FITC/IGFG1 PE/CD45 PERCP (K950057)Becton Dickinson Immunocytometry Systems1995-08-22
OPTICLONE CD4FITC/CD8 PE MONOCLONAL ANTIBODIES (K952789)Immunotech Corp.1995-08-14
COULTER MH025A (K950949)Coulter Corp.1995-07-20
OPTICLONE CD3/CD8 MONOCLONAL ANTIBODIES (K952182)Immunotech, Inc.1995-07-05
CALTAG CD8 FITC AND CD8 R-PE MONOCLONAL ANTIBODIES (K944126)Caltag Laboratories, Inc.1995-06-20
CALTAG CD4 R-PE MONOCLONAL ANTIBODY (K944128)Caltag Laboratories, Inc.1995-06-20
CALTAG CD3 FITC, R-PE, TRI-COLOR MONOCLONAL ANTIBODY (K944127)Caltag Laboratories, Inc.1995-06-20
SYSMEX(TM) F-820, 520 (K945837)Sysmex Corp.1995-06-09
TRAX(TM) CD4 TEST KIT (K925255)T Cell Diagnostics, Inc.1995-05-15
OPTICLONE CD3/CD4 MONOCLONAL ANTIBODIES (K950626)Immunotech Corp.1995-05-05
ORTHO-MUNE OKT8 (CD8) MONOCLONAL ANTIBODY (MURINE) (K932532)Ortho Diagnostic Systems, Inc.1995-04-26
ORTHO-MUNE OKT 4 (CD4) MONOCLONAL ANTIBODY MURINE (K932531)Ortho Diagnostic Systems, Inc.1995-04-26
ORTHO-MUNE OKT 3 MONOCLONAL ANTIBODY (MURINE) (K932530)Ortho Diagnostic Systems, Inc.1995-04-26
ORTHO-MUNE 0KT 11 (CD2) MONOCLONAL ANTIBODY (MURINE) (K941713)Ortho Diagnostic Systems, Inc.1995-04-26
ONYX (K943967)Coulter Corp.1995-03-06
SYSMEX K-4500 (K943894)Sysmex Corp.1995-02-03
MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD2, CLONE MT910 FITC-CONJUGATED, (ANTI-CD2,FITC, MT910) (K945692)Dako Corp.1995-01-25
TECHNICON H* 3 RTC SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM) (K941171)Miles, Inc.1994-12-14
MONOCLONAL MOUSE ANTI-HUMAN B-CELL (K943284)Dako Corp.1994-11-21
MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD8, RPE-CONJUGATED, CLONE DK25 (K944253)Dako Corp.1994-11-21
MONOCLONAL MOUSE ANTI-HUMAN T-CELL (K942797)Dako Corp.1994-11-10
GENESIS 1, AUTOMATED CELL COUNTER, MODIFICATION (K925909)Alicia Diagnostics, Inc.1994-10-27
AUTOCOMP(TM) SOFTWARE AND CALIBRITE(TM) BEADS (K925274)Becton Dickinson Immunocytometry Systems1994-09-30
FASCOUNT SYSTME (K933486)Becton Dickinson Immunocytometry Systems1994-09-09
SYSMEX SE-9000 AUTOMATED HEMATOLOGY ANALYZER (K936023)Toa Medical Electronics USA, Inc.1994-05-02
TECHNICON H*1 SYSTEMS, LABFACTS SOFTWARE FOR U.I.W. VERSIONS 4.11 & 5.11 (K933478)Miles, Inc.1993-11-22
TECHNICON H* 2 SYSTEM, LABFACTS SOFTWARE FOR U.I.W. VERSIONS 4.11 & 5.11 (K933475)Miles, Inc.1993-11-22
FACSORT FLOW CYTOMETER (K923790)Becton Dickinson Immunocytometry Systems1993-09-01
COULTER MH015 (DIFFERENTIAL CELL COUNTER) (K930913)Coulter Corp.1993-08-23
COULTER STKS WITH RETICULOCYTE ANALYSIS CAPABILITY (K932030)Coulter Corp.1993-08-23
SIMULTEST CD3/ANTI-HLA-DR (K924587)Becton Dickinson Immunocytometry Systems1993-08-05
ABBOTT ENCOUNTER(TM)Q (K930309)Abbott Laboratories1993-07-14
CYTO-STAT/COULTER CLONE CD3 (IGG1)-FITC/B4-RD1 MON (K926124)Coulter Corp.1993-07-06
TECHNICON H* 3 RTX SYSTEM (IN-VITRO DIAG. SYSTEM) (K930148)Heraeus Kulzer, Inc.1993-05-11
CYTO-STAT/COULTER CLONE CD 3(IGG1)-FITC/T8-RD1 (K922744)Coulter Immunology1993-02-05
BIOVATION K-MANAGER (K925528)Biovation, Inc.1993-02-05
CYTO-STAT/COULTER CLONE CD3(IGG1)-FITC/T4-RD1 (K922745)Coulter Immunology1993-02-05
CELLEXIS HEMATOLOGY ANALYZER (K923773)Technalysis, Inc.1993-02-05
COULTER NEW METH BLUE PREPREP RETIC/MAXM W/AUTOLOA (K925344)Coulter Corp.1993-01-21
CD4 CYTOSPHERES KIT (K921279)Coulter Electronics, Inc.1992-12-29
TECHNICON H*2 (K923237)Heraeus Kulzer, Inc.1992-09-11
COULTER MH009 (K922181)Coulter Electronics, Inc.1992-08-17
MONOMCLONAL ANTIBODY IGG1 ISOTYPE CONT. FLOW CYTOM (K922084)Gen Trak, Inc.1992-07-28
MONOCLONAL ANTIBODY IGG2A ISOTYPE CONT. FLOW CYTOM (K922085)Gen Trak, Inc.1992-07-28
COULTER MAXM W/ AUTOLOADER (K922704)Coulter Electronics, Inc.1992-07-27
COULTER MH017 (K921567)Coulter Electronics, Inc.1992-07-06
CD4 MONOCLONAL ANTIBODIES (K914848)Gen Trak, Inc.1992-06-19
CD2 MONOCLONAL ANTIBODIES (K914846)Gen Trak, Inc.1992-06-19
SOFTWARE MODIFICATION FOR MILES H*1 S/W VER. 1.5 (K920949)Heraeus Kulzer, Inc.1992-05-15
SYSMEX HEMATOLOGY SYSTEM ACCESSORIES (K920544)Toa Medical Electronics USA, Inc.1992-04-29
SIMULTEST(TM) IMK-LYMPHOCYTE (K913192)Bd Becton Dickinson Vacutainer Systems Preanalytic1992-02-06
DIFFERENTIAL COUNTING BOARD (K915071)Biovation, Inc.1992-01-17
SYSMEX NE-1500, MODIFICATION (K914744)Toa Medical Electronics USA, Inc.1991-12-30
FACSTRAK FLOW CYTOMETER (K914014)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-12-04
CELL-DYN 3000A MULTI-PARAMETER AUTO HEMA ANALZYER (K913305)Unipath , Ltd.1991-11-22
MONOCLONAL ANTIBODY ANTI-CD5 (K901188)Sigma Chemical Co.1991-10-31
CYTO-STAT(R)/COULTER CLONE(R) T11-RD1/B4-FITC (K910473)Coulter Immunology1991-10-31
MONOCLONAL ANTIBODY ANTI-CD2 (K901187)Sigma Chemical Co.1991-10-31
MONOCLONAL ANTIBODY ANTI-CD19 (K901186)Sigma Chemical Co.1991-10-31
MONOCLONAL ANTIBODY ANTI-CD3 (K901189)Sigma Chemical Co.1991-10-31
NOVA CELLTRAK 12 AUTO MULTI-PARA HEMA ANALYZER/CAL (K913259)Nova Biomedical Corp.1991-10-08
SYSTEM 9000, INTERPRETIVE DIFF CELL COUNTER (K911626)Serono Baker Diagnostics System1991-09-13
COULTERCLONE (K911793)Coulter Immunology1991-07-09
COULTER(R) MH010 (K911385)Coulter Electronics, Inc.1991-06-17
ORTHO MUNE OKT3,4, AND 8 MONOCLONAL ANTIBODY (K904253)Ortho Diagnostic Systems, Inc.1991-05-20
QBC AUTOREADER (K910834)Bd Becton Dickinson Vacutainer Systems Preanalytic1991-05-07
DANAM DATACELL-18 (K910283)Danam Electronics1991-04-12
ANTI-HUMAN LEU-2A (CD8) PE (K904390)Bd Becton Dickinson Vacutainer Systems Preanalytic1990-12-17
SIMULTEST T & B CELL TEST,ANTI-LEU-4 FITC & 12 PE (K904209)Bd Becton Dickinson Vacutainer Systems Preanalytic1990-12-11
CELL-DYN 1400 MULTI-PARAMETER AUTOMATED HEMATOLOGY (K903665)Unipath , Ltd.1990-10-04
ANTI-HUMAN LEU-3A (CD4) FITC (K900802)Bd Becton Dickinson Vacutainer Systems Preanalytic1990-05-15
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