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.

3297
Total
3290
Cleared
164d
Avg (2y)
1976
Since
3297 Hematology devices
1101–1125 of 3297
Cleared Mar 28, 1997
GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEM
K962687 · Nichols Institute Diagnostics
JQW · Station, Pipetting And Diluting, For Clinical Use · 260d
Cleared Mar 18, 1997
THROMBONOSTIKA F1.2
K964934 · Organon Teknika Corp.
MIF · Prothrombin Fragment 1.2 · 99d
Cleared Mar 18, 1997
SYSMEX CA-1000/SYSMEX CA-5000
K964946 · Sysmex Corp.
JPA · System, Multipurpose For In Vitro Coagulation Studies · 98d
Cleared Mar 18, 1997
MDA HEPARIN ANTI-X ASSAY
K965076 · Organon Teknika Corp.
KFF · Assay, Heparin · 89d
Cleared Mar 13, 1997
SYSMEX SE/RAM-1
K964375 · Sysmex Corp.
GKL · Counter, Cell, Automated (particle Counter) · 132d
Cleared Mar 12, 1997
PROTIME MICROCOAGULATION SYSTEM
K961835 · International Technidyne Corp.
GJS · Test, Time, Prothrombin · 303d
Cleared Mar 07, 1997
SPECKTIN-LA TEST SET
K961892 · Analytical Control Systems, Inc.
GFO · Activated Partial Thromboplastin · 295d
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

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All categories 3297 GKZ Counter, Differential Cell 378 GGP Test, Qualitative And Quantitative Factor Deficiency 188 JPK Mixture, Hematology Quality Control 186 JPA System, Multipurpose For In Vitro Coagulation Studies 181 GKL Counter, Cell, Automated (particle Counter) 124 GJS Test, Time, Prothrombin 123 LCP Assay, Glycosylated Hemoglobin 123 GGN Plasma, Coagulation Control 98 KHE Reagent, Occult Blood 85 GJT Plasma, Coagulation Factor Deficient 79 DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control 56 GFO Activated Partial Thromboplastin 50 GKP Instrument, Coagulation, Automated 49 JBQ Antithrombin Iii Quantitation 48 KFF Assay, Heparin 45