FDA Review Panel · HE

FDA 510(k) Hematology Devices

FDA 510(k) Hematology Devices - Regulatory Overview

FDA 510(k) hematology devices include automated instruments used to analyze blood composition and coagulation. The FDA review panel code is HE.

Key device categories:

  • Complete blood count (CBC) analyzers - automated cell counters for RBC, WBC and platelets
  • Coagulation analyzers - PT/INR, aPTT, fibrinogen and factor assays
  • Flow cytometry systems - immunophenotyping and cell sorting
  • Blood typing and cross-match systems - transfusion medicine instruments

Most hematology devices are classified as Class II under 21 CFR Part 864. Data sourced from FDA 510(k) public files. Updated monthly.

3294
Total
3287
Cleared
164d
Avg (2y)
1976
Since
2617 Hematology devices
976–1000 of 2617
Cleared Mar 06, 1997
ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE)
K951632 · Ortho Diagnostic Systems, Inc.
GKZ · Counter, Differential Cell · 699d
Cleared Mar 06, 1997
SPIRIT HEMATOLOGY SYSTEM MODEL LE, CP, & AX
K960072 · Biochem Immunosystems (U.S.), Inc.
GKZ · Counter, Differential Cell · 426d
Cleared Mar 06, 1997
ACTALYKE ACTIVATED CLOTTING TIME TEST SYSTEM/CLOTTING TIME TUBES/WHOLE BLOOD QC KIT/ACTALYKE ELECTRONIC CLOTTING TUBE
K964609 · Array Medical, Inc.
JBP · Activated Whole Blood Clotting Time · 108d
Cleared Mar 06, 1997
COULTER AC.T SERIES ANALYZER
K964988 · Coulter Corp.
GKZ · Counter, Differential Cell · 83d
Cleared Feb 20, 1997
HEMATACHEK
K964452 · Richmond Diagnostics, Inc.
GLK · Control, Hematocrit · 106d
Cleared Feb 20, 1997
LYPHOCHEK COAGULATION CONTROL
K964963 · Bio-Rad
GGN · Plasma, Coagulation Control · 71d
Cleared Feb 18, 1997
STRATEC LIA II ANALYZER
K961142 · Nichols Institute Diagnostics
JJE · Analyzer, Chemistry (photometric, Discrete), For Clinical Use · 334d
Cleared Feb 06, 1997
SYSMEX CA-6000
K964139 · Dade Intl., Inc.
GKP · Instrument, Coagulation, Automated · 114d
Cleared Jan 22, 1997
COAG-A-MATE MTX
K962857 · Organon Teknika Corp.
GKP · Instrument, Coagulation, Automated · 184d
Cleared Jan 22, 1997
TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS AND CYTO-STAT TERTRACHROME CD45-FITC/CD4-RDI/CD8-ECD/CD3-PC5
K963263 · Coulter Corp.
GKZ · Counter, Differential Cell · 155d
Cleared Jan 22, 1997
ORTHO-MUNE OKB (CD19)- MONOCLONAL ANTIBODY (MURINE) PHYCOERYTHRINE CONJUGATE
K964754 · Ortho Diagnostic Systems, Inc.
GKZ · Counter, Differential Cell · 56d
Cleared Jan 17, 1997
CD3 FITC/CD19 R-PE/CD45 TRI-COLOR MONOCLONAL ANTIBODY COMBINATION
K964856 · Caltag Laboratories, Inc.
GKZ · Counter, Differential Cell · 44d
Cleared Jan 06, 1997
CYTO-STAT TRICHROME CD45-FITC/CD8-RD1/CD3-PC5 MONOCLONAL ANTIBODY REAGENT IWTH ISOTYPIC CONTROL
K962305 · Coulter Corp.
GKZ · Counter, Differential Cell · 203d
Cleared Jan 06, 1997
CYTO-STAT TRICHROME CD45-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANITBODY REAGENT W/ISOTYPIC CONTROL
K962768 · Coulter Corp.
GKZ · Counter, Differential Cell · 203d
Cleared Dec 23, 1996
COATEST APC (TM) RESISTANCE V/COATEST APC (TM) RESISTANCE V S
K963111 · Chromogenix AB
GGW · Test, Time, Partial Thromboplastin · 133d
Cleared Dec 23, 1996
CYTO-STAT TRICHROME CD8-FITC/CD4-RDI/CD3-PC5 MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT TRICHROME MSIGGI-FITC/MSIGGI-RD1
K964618 · Coulter Corp.
GKZ · Counter, Differential Cell · 69d
Cleared Dec 18, 1996
THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS
K962864 · Alko Diagnostic Corp.
KRZ · Calibrator For Hemoglobin And Hematocrit Measurement · 148d
Cleared Dec 18, 1996
UNIVERSAL REAGENT FACTOR V DEFICIENT PLASMA
K964270 · Universal Reagents, Inc.
GGP · Test, Qualitative And Quantitative Factor Deficiency · 54d
Cleared Dec 18, 1996
UNIVERSAL REAGENT FACTOR X DEFICIENT PLASMA
K964459 · Universal Reagents, Inc.
GGP · Test, Qualitative And Quantitative Factor Deficiency · 41d
Cleared Dec 13, 1996
PROC APC ASSAY, PROC CONTROL PLASMA
K962968 · Behring Diagnostics, Inc.
GGP · Test, Qualitative And Quantitative Factor Deficiency · 136d
Cleared Dec 12, 1996
MULTISET SOFTWARE FOR AUTOMATED FLOW CYTOMETRIC DATA ANALYSIS
K963963 · Becton Dickinson Immunocytometry Systems
GKZ · Counter, Differential Cell · 71d
Cleared Dec 10, 1996
THOR HENOSTATSIS ANALYZER CAT. NO. 1450, 1451
K961908 · Helena Laboratories
JPA · System, Multipurpose For In Vitro Coagulation Studies · 208d
Cleared Nov 29, 1996
QUANTITATIVE FIBRINOGEN ASSAY
K963902 · Ortho Diagnostic Systems, Inc.
GIS · Test, Fibrinogen · 63d
Cleared Nov 25, 1996
CD 19 R-PE, CD19 TRI-COLOR MONOCLONAL ANTIBODY
K963954 · Caltag Laboratories, Inc.
GKZ · Counter, Differential Cell · 54d
Cleared Nov 18, 1996
CHROMOLIZE PAI-1 KIT
K963106 · Medical Diagnostic Technologies, Inc.
GGP · Test, Qualitative And Quantitative Factor Deficiency · 98d

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All categories 2617 GKZ Counter, Differential Cell 301 JPK Mixture, Hematology Quality Control 164 JPA System, Multipurpose For In Vitro Coagulation Studies 159 GGP Test, Qualitative And Quantitative Factor Deficiency 157 GJS Test, Time, Prothrombin 111 LCP Assay, Glycosylated Hemoglobin 97 GKL Counter, Cell, Automated (particle Counter) 97 GGN Plasma, Coagulation Control 93 GJT Plasma, Coagulation Factor Deficient 75 KHE Reagent, Occult Blood 55 DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control 50 GKP Instrument, Coagulation, Automated 46 GFO Activated Partial Thromboplastin 42 JBQ Antithrombin Iii Quantitation 40 GGC Control, Plasma, Abnormal 37