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GKZ

380 FDA 510(k) clearances · Product code

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RecordFirmDate
RDW AND MPV INDICES ON HEMAT 12 (K900684)Texas Intl. Laboratories, Inc.1990-04-16
EXACT ONE(TM) HEMATOLOGY ANALYZER (K900276)Exact Science, Inc.1990-04-16
SIMULTEST IMK PLUS(TM) (K900078)Bd Becton Dickinson Vacutainer Systems Preanalytic1990-04-02
COULTER JT3 (K896873)Coulter Corp.1990-03-30
TECHNICON H*2(TM) SYSTEM (K900593)Technicon Instruments Corp.1990-03-14
COULTER CLONE T4 MONOCLONAL ANTIBODY (K893852)Coulter Immunology1990-03-02
COULTER CLONE T8 MONOCLONAL ANTIBODY (K893853)Coulter Immunology1990-03-02
COULTER CLONE(R) MY4 MONOCLONAL ANTIBODY (K894179)Coulter Immunology1990-02-12
CYTO-STAT/COULTER CLONE T4-RD1/T8-FITC MONO ANTI (K895917)Coulter Immunology1989-12-29
SIMULTEST IMK FOR FACS ANALYZER OR FACSCAN (K890349)Becton Dickinson Immunocytometry Systems1989-12-29
ARGOS (K895127)Abx, Inc.1989-10-10
COULTER CLONE MO2 (K884605)Coulter Immunology1989-08-15
QBC MALARIA SYSTEM (K891276)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-08-03
QBC III CENTRIFUGAL HEMATOLOGY SYSTEM (K893423)Bd Becton Dickinson Vacutainer Systems Preanalytic1989-06-20
DANAM VECTOR-8+ (K892205)Danam Electronics1989-06-13
CELL-DYN 3000 MULTI-PARAMETER HEMATOLOGY ANALYER (K890491)Abbott Diagnostics1989-04-18
COULTER 5P CONTROL (K885028)Coulter Electronics, Inc.1989-02-16
COULTER CLONE T3 MONOCLONAL ANTIBODY (K883710)Coulter Immunology1989-02-03
COULTER CLONE B4 MONOCLONAL ANTIBODY (K884020)Coulter Immunology1989-02-03
COULTER CLONE T1 MONOCLONAL ANTIBODY (K883753)Coulter Immunology1989-02-03
COULTER STKS (K885093)Coulter Electronics, Inc.1988-12-28
CYTO-STAT/COULTER CLONE T11-RD1/B1-FITC MONO. ANTI (K884346)Coulter Immunology1988-12-27
SYSMEX NE-8000 (K883997)Toa Medical Electronics USA, Inc.1988-12-05
HEMAT 12 (K884006)Texas Intl. Laboratories, Inc.1988-12-05
H 10 OR HEMATIL 10 BLOOD CELL & PLATELET COUNTER (K883177)Texas Intl. Laboratories, Inc.1988-11-30
COULTER CLONE B1 MONOCLONAL ANTIBODY (K882557)Coulter Immunology1988-09-14
SYSTEM 9000 DIFF MODEL AUTOMATED CELL COUNTER (K882612)Baker Instructions Corp.1988-09-07
HEMATRAK(R) MODEL 590 (K882579)Priority Service Systems1988-09-07
SYSMEX K-1000 18 PARAMETER, AUTO. HEMA ANALYZER (K882370)Toa Medical Electronics USA, Inc.1988-08-25
MINOS AUTOMATIC CELL COUNTER (K880616)Abx, Inc.1988-05-02
AUTOLYZER 801 SYSTEM (AUTOMATED CELL COUNTER) (K875346)Contraves Medical Instruments, Inc.1988-04-07
COULTER VCS LEUKOCYTE DIFFERENTIAL COUNTER (K880507)Coulter Electronics, Inc.1988-04-04
COULTER CLONE T11 MONOCLONAL ANTIBODY (K875047)Coulter Electronics, Inc.1988-03-09
COULTER COUNTER MODEL T SERIES W/2-PART DIFFERENT. (K874838)Coulter Electronics, Inc.1988-02-19
CELLECT MODEL D, AUTOMATED HEMTALOGY ANALYZER (K874763)Instrumentation Laboratory CO1988-02-18
QBC BLOOD BANK SYSTEM (K874147)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-01-11
QBC SYSTEM HEMOGLOBIN (K874427)Bd Becton Dickinson Vacutainer Systems Preanalytic1988-01-05
SYSMEX F-800 15 PARAMETER, SEMI-AUTO HEMA ANALYZER (K873734)Toa Medical Electronics USA, Inc.1987-11-25
MICRO-COUNT DIFFHE (K873256)Toni Diagnostics, Inc.1987-11-06
CELL-DYN 610 HEMATOLOGY ANALYZER (K872761)Abbott Diagnostics1987-08-06
MINOS AUTOMATIC CELL COUNTER (K864579)Abx, Inc.1987-07-16
COULTER COUNTER MODEL S-PLUS STKR (K871837)Coulter Electronics, Inc.1987-07-02
SYSMEX M-2000 18-PARAMETER, FULLY AUTO HEMA ANALY. (K871600)Toa Medical Electronics USA, Inc.1987-06-24
CELL-DYN 1600 MULTIPARAMETER AUTO. HEMA. ANALYZER (K870233)Abbott Diagnostics1987-03-17
SYSMEX E-2500 AUTOMATED HEMATOLOGY SYSTEM (K855117)Toa Medical Electronics USA, Inc.1986-02-24
SYSMEX E-5000 FULLY AUTOMATED HEMATOLOGY SYSTEM (K855116)Toa Medical Electronics USA, Inc.1986-02-24
TECHNICON H*1 SYSTEM (MPXI) (K853027)Technicon Instruments Corp.1986-02-05
TECHNICON H*1 SYSTEM LOBULARITY INDX/LFT SHIFT FLA (K853029)Technicon Instruments Corp.1986-01-24
TECHNICON H*1 SYSTEM SUB-CLASSIFICATION LUC CAT. (K852988)Technicon Instruments Corp.1986-01-21
CELL-DYN 1500 MULTI-PARAMETER HEMATOLOGY ANALYZER (K854368)Abbott Diagnostics1986-01-01
QBC CENTRIFUGAL HEMATOLOGY SYSTEM (K854242)Bd Becton Dickinson Vacutainer Systems Preanalytic1986-01-01
21 HEMATOLOGY REAGENTS (K853304)In Vitro Diagnostics, Inc.1985-11-12
CELL-DYN 2000 AUTOMATED MULTI-PARAMETER HEMATOLOGY (K852371)Abbott Diagnostics1985-09-17
SYSMEX E-5000, FULLY AUTOMATED HEMATOLOGY SYS (K850354)Toa Medical Electronics USA, Inc.1985-05-20
SYSMEX CC-800/PDA-410 W/TRI-MODAL LEUKOCYTE SIZE - (K844910)Toa Medical Electronics USA, Inc.1985-04-01
QBC CENTRIFUGAL HEMATOLOGY ANALYZER (K844645)Bd Becton Dickinson Vacutainer Systems Preanalytic1985-03-05
AUTOLYZER 800 (K841852)Geometric Data, Div. Smithkline Corp.1984-09-05
TECHNICON H*1 SYSTEM (K842636)Technicon Instruments Corp.1984-07-27
FACS ANALYZER (K840195)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-04-30
ORTHO ELT-8/DS HEMATOLOGY ANALYZER (K833618)Ortho Diagnostic Systems, Inc.1984-01-13
COULTER COUNTER MODEL S-PLUS V (K833600)Coulter Electronics, Inc.1984-01-10
ELT-8/DS HEMATOLOGY ANALYZER & LYSRIG (K831271)Ortho Diagnostic Systems, Inc.1983-07-26
COULTER-COUNTER #S PLUS IV & LYSE S +D (K823355)Coulter Electronics, Inc.1982-12-28
PENETRAK TM (K821186)Syva Co.1982-06-25
ADC-500 AUTOMATED DIFFER. CELL CNTR. SY. (K803219)Abbott Laboratories1981-01-21
ADD OF RETICULOCYTE COUNT/CAPABILITIES (K800533)Abbott Laboratories1980-04-04
TECHNICON C/90 SYSTEM (K800121)Technicon Instruments Corp.1980-02-05
COULTER DIFF3 SYS. (COULTER #7400003) (K791903)Coulter Electronics, Inc.1979-10-30
HEMATRAK ABNORMAL RECOGNITION (K791041)Geometric Data, Div. Smithkline Corp.1979-09-04
HEMATRAK MODEL 480 (K790816)Geometric Data, Div. Smithkline Corp.1979-07-17
CONTEXT FILTER (K791108)Geometric Data, Div. Smithkline Corp.1979-07-17
PRINTER, TEK PRO TEK TALLY II (K782050)Tekpro1979-01-03
PLATELETS/CU MM (K780577)Geometric Data, Div. Smithkline Corp.1978-05-19
HEMATRAK RBC MORPHOLOGY (K761207)Geometric Data, Div. Smithkline Corp.1977-10-18
AUTO DIFFERENTIAL CELL COUNTER SYSTEM (K770244)Abbott Laboratories1977-08-04
HEMATRAK (K770680)Geometric Data, Div. Smithkline Corp.1977-07-01
ATYPIA PROFILE MONITOR (K770550)Geometric Data, Div. Smithkline Corp.1977-06-17
HEMATRAK MODEL 125 (K770701)Geometric Data, Div. Smithkline Corp.1977-06-03
ATYPICAL LYMPHOCYTE & NCB CLASSIFICATION (K770869)Geometric Data, Div. Smithkline Corp.1977-06-02
HEMATRAK MATURITY PROFILE OPTION (K761208)Geometric Data, Div. Smithkline Corp.1977-02-28
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