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Counter, Differential Cell

FDA product code GKZ · 375 cleared devices

Class 2 Hematology

Regulation: 21 CFR 864.5220
Review panel: HE
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1977-02-28 – 2026-09-14

GKZ 1990-03-02

COULTER CLONE T8 MONOCLONAL ANTIBODY

Applicant Coulter Immunology

K number K893853

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GKZ 1990-03-02

COULTER CLONE T4 MONOCLONAL ANTIBODY

Applicant Coulter Immunology

K number K893852

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GKZ 1990-02-12

COULTER CLONE(R) MY4 MONOCLONAL ANTIBODY

Applicant Coulter Immunology

K number K894179

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GKZ 1989-12-29

CYTO-STAT/COULTER CLONE T4-RD1/T8-FITC MONO ANTI

Applicant Coulter Immunology

K number K895917

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GKZ 1989-12-29

SIMULTEST IMK FOR FACS ANALYZER OR FACSCAN

Applicant Becton Dickinson Immunocytometry Systems

K number K890349

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GKZ 1989-10-10

ARGOS

Applicant Abx, Inc.

K number K895127

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GKZ 1989-08-15

COULTER CLONE MO2

Applicant Coulter Immunology

K number K884605

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GKZ 1989-08-03

QBC MALARIA SYSTEM

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K891276

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GKZ 1989-06-20

QBC III CENTRIFUGAL HEMATOLOGY SYSTEM

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K893423

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GKZ 1989-06-13

DANAM VECTOR-8+

Applicant Danam Electronics

K number K892205

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GKZ 1989-04-18

CELL-DYN 3000 MULTI-PARAMETER HEMATOLOGY ANALYER

Applicant Abbott Diagnostics

K number K890491

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GKZ 1989-02-16

COULTER 5P CONTROL

Applicant Coulter Electronics, Inc.

K number K885028

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GKZ 1989-02-03

COULTER CLONE B4 MONOCLONAL ANTIBODY

Applicant Coulter Immunology

K number K884020

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GKZ 1989-02-03

COULTER CLONE T1 MONOCLONAL ANTIBODY

Applicant Coulter Immunology

K number K883753

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GKZ 1989-02-03

COULTER CLONE T3 MONOCLONAL ANTIBODY

Applicant Coulter Immunology

K number K883710

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GKZ 1988-12-28

COULTER STKS

Applicant Coulter Electronics, Inc.

K number K885093

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GKZ 1988-12-27

CYTO-STAT/COULTER CLONE T11-RD1/B1-FITC MONO. ANTI

Applicant Coulter Immunology

K number K884346

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GKZ 1988-12-05

HEMAT 12

Applicant Texas Intl. Laboratories, Inc.

K number K884006

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GKZ 1988-12-05

SYSMEX NE-8000

Applicant Toa Medical Electronics USA, Inc.

K number K883997

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GKZ 1988-11-30

H 10 OR HEMATIL 10 BLOOD CELL & PLATELET COUNTER

Applicant Texas Intl. Laboratories, Inc.

K number K883177

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GKZ 1988-09-14

COULTER CLONE B1 MONOCLONAL ANTIBODY

Applicant Coulter Immunology

K number K882557

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GKZ 1988-09-07

SYSTEM 9000 DIFF MODEL AUTOMATED CELL COUNTER

Applicant Baker Instructions Corp.

K number K882612

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GKZ 1988-09-07

HEMATRAK(R) MODEL 590

Applicant Priority Service Systems

K number K882579

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GKZ 1988-08-25

SYSMEX K-1000 18 PARAMETER, AUTO. HEMA ANALYZER

Applicant Toa Medical Electronics USA, Inc.

K number K882370

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GKZ 1988-05-02

MINOS AUTOMATIC CELL COUNTER

Applicant Abx, Inc.

K number K880616

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GKZ 1988-04-07

AUTOLYZER 801 SYSTEM (AUTOMATED CELL COUNTER)

Applicant Contraves Medical Instruments, Inc.

K number K875346

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GKZ 1988-04-04

COULTER VCS LEUKOCYTE DIFFERENTIAL COUNTER

Applicant Coulter Electronics, Inc.

K number K880507

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GKZ 1988-03-09

COULTER CLONE T11 MONOCLONAL ANTIBODY

Applicant Coulter Electronics, Inc.

K number K875047

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GKZ 1988-02-19

COULTER COUNTER MODEL T SERIES W/2-PART DIFFERENT.

Applicant Coulter Electronics, Inc.

K number K874838

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GKZ 1988-02-18

CELLECT MODEL D, AUTOMATED HEMTALOGY ANALYZER

Applicant Instrumentation Laboratory CO

K number K874763

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GKZ 1988-01-11

QBC BLOOD BANK SYSTEM

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K874147

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GKZ 1988-01-05

QBC SYSTEM HEMOGLOBIN

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K874427

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GKZ 1987-11-25

SYSMEX F-800 15 PARAMETER, SEMI-AUTO HEMA ANALYZER

Applicant Toa Medical Electronics USA, Inc.

K number K873734

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GKZ 1987-11-06

MICRO-COUNT DIFFHE

Applicant Toni Diagnostics, Inc.

K number K873256

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GKZ 1987-08-06

CELL-DYN 610 HEMATOLOGY ANALYZER

Applicant Abbott Diagnostics

K number K872761

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GKZ 1987-07-16

MINOS AUTOMATIC CELL COUNTER

Applicant Abx, Inc.

K number K864579

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GKZ 1987-07-02

COULTER COUNTER MODEL S-PLUS STKR

Applicant Coulter Electronics, Inc.

K number K871837

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GKZ 1987-06-24

SYSMEX M-2000 18-PARAMETER, FULLY AUTO HEMA ANALY.

Applicant Toa Medical Electronics USA, Inc.

K number K871600

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GKZ 1987-03-17

CELL-DYN 1600 MULTIPARAMETER AUTO. HEMA. ANALYZER

Applicant Abbott Diagnostics

K number K870233

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GKZ 1986-02-24

SYSMEX E-2500 AUTOMATED HEMATOLOGY SYSTEM

Applicant Toa Medical Electronics USA, Inc.

K number K855117

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GKZ 1986-02-24

SYSMEX E-5000 FULLY AUTOMATED HEMATOLOGY SYSTEM

Applicant Toa Medical Electronics USA, Inc.

K number K855116

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GKZ 1986-02-05

TECHNICON H*1 SYSTEM (MPXI)

Applicant Technicon Instruments Corp.

K number K853027

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GKZ 1986-01-24

TECHNICON H*1 SYSTEM LOBULARITY INDX/LFT SHIFT FLA

Applicant Technicon Instruments Corp.

K number K853029

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GKZ 1986-01-21

TECHNICON H*1 SYSTEM SUB-CLASSIFICATION LUC CAT.

Applicant Technicon Instruments Corp.

K number K852988

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GKZ 1986-01-01

CELL-DYN 1500 MULTI-PARAMETER HEMATOLOGY ANALYZER

Applicant Abbott Diagnostics

K number K854368

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GKZ 1986-01-01

QBC CENTRIFUGAL HEMATOLOGY SYSTEM

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K854242

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GKZ 1985-11-12

21 HEMATOLOGY REAGENTS

Applicant In Vitro Diagnostics, Inc.

K number K853304

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GKZ 1985-09-17

CELL-DYN 2000 AUTOMATED MULTI-PARAMETER HEMATOLOGY

Applicant Abbott Diagnostics

K number K852371

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GKZ 1985-05-20

SYSMEX E-5000, FULLY AUTOMATED HEMATOLOGY SYS

Applicant Toa Medical Electronics USA, Inc.

K number K850354

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GKZ 1985-04-01

SYSMEX CC-800/PDA-410 W/TRI-MODAL LEUKOCYTE SIZE -

Applicant Toa Medical Electronics USA, Inc.

K number K844910

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GKZ 1985-03-05

QBC CENTRIFUGAL HEMATOLOGY ANALYZER

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K844645

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GKZ 1984-09-05

AUTOLYZER 800

Applicant Geometric Data, Div. Smithkline Corp.

K number K841852

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GKZ 1984-07-27

TECHNICON H*1 SYSTEM

Applicant Technicon Instruments Corp.

K number K842636

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GKZ 1984-04-30

FACS ANALYZER

Applicant Bd Becton Dickinson Vacutainer Systems Preanalytic

K number K840195

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GKZ 1984-01-13

ORTHO ELT-8/DS HEMATOLOGY ANALYZER

Applicant Ortho Diagnostic Systems, Inc.

K number K833618

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GKZ 1984-01-10

COULTER COUNTER MODEL S-PLUS V

Applicant Coulter Electronics, Inc.

K number K833600

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GKZ 1983-07-26

ELT-8/DS HEMATOLOGY ANALYZER & LYSRIG

Applicant Ortho Diagnostic Systems, Inc.

K number K831271

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GKZ 1982-12-28

COULTER-COUNTER #S PLUS IV & LYSE S +D

Applicant Coulter Electronics, Inc.

K number K823355

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GKZ 1982-06-25

PENETRAK TM

Applicant Syva Co.

K number K821186

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GKZ 1981-01-21

ADC-500 AUTOMATED DIFFER. CELL CNTR. SY.

Applicant Abbott Laboratories

K number K803219

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GKZ 1980-04-04

ADD OF RETICULOCYTE COUNT/CAPABILITIES

Applicant Abbott Laboratories

K number K800533

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GKZ 1980-02-05

TECHNICON C/90 SYSTEM

Applicant Technicon Instruments Corp.

K number K800121

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GKZ 1979-10-30

COULTER DIFF3 SYS. (COULTER #7400003)

Applicant Coulter Electronics, Inc.

K number K791903

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GKZ 1979-09-04

HEMATRAK ABNORMAL RECOGNITION

Applicant Geometric Data, Div. Smithkline Corp.

K number K791041

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GKZ 1979-07-17

CONTEXT FILTER

Applicant Geometric Data, Div. Smithkline Corp.

K number K791108

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GKZ 1979-07-17

HEMATRAK MODEL 480

Applicant Geometric Data, Div. Smithkline Corp.

K number K790816

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GKZ 1979-01-03

PRINTER, TEK PRO TEK TALLY II

Applicant Tekpro

K number K782050

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GKZ 1978-05-19

PLATELETS/CU MM

Applicant Geometric Data, Div. Smithkline Corp.

K number K780577

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GKZ 1977-10-18

HEMATRAK RBC MORPHOLOGY

Applicant Geometric Data, Div. Smithkline Corp.

K number K761207

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GKZ 1977-08-04

AUTO DIFFERENTIAL CELL COUNTER SYSTEM

Applicant Abbott Laboratories

K number K770244

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GKZ 1977-07-01

HEMATRAK

Applicant Geometric Data, Div. Smithkline Corp.

K number K770680

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GKZ 1977-06-17

ATYPIA PROFILE MONITOR

Applicant Geometric Data, Div. Smithkline Corp.

K number K770550

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GKZ 1977-06-03

HEMATRAK MODEL 125

Applicant Geometric Data, Div. Smithkline Corp.

K number K770701

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GKZ 1977-06-02

ATYPICAL LYMPHOCYTE & NCB CLASSIFICATION

Applicant Geometric Data, Div. Smithkline Corp.

K number K770869

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GKZ 1977-02-28

HEMATRAK MATURITY PROFILE OPTION

Applicant Geometric Data, Div. Smithkline Corp.

K number K761208

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