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
926–950 of 2617
Cleared Aug 26, 1997
TRUCOUNT ABSOLUTE COUNT TUBES/COUNTING CONTROL BEADS
K970836 · Becton Dickinson Immunocytometry Systems
GKZ · Counter, Differential Cell · 183d
Cleared Aug 26, 1997
SYSMEX IMMATURE RETICULOCYTE FRACTION (IRF) PARAMETER
K971736 · Sysmex Corp.
GKZ · Counter, Differential Cell · 106d
Cleared Aug 19, 1997
CRYO CHECK APC RESISTANT PLASMA
K971222 · Precision Biologicals, Inc.
GGN · Plasma, Coagulation Control · 139d
Cleared Aug 19, 1997
ASSERACHROM TPA TEST KIT
K971519 · American Bioproducts Co.
GGP · Test, Qualitative And Quantitative Factor Deficiency · 116d
Cleared Aug 18, 1997
TRACCELL 2000 SLIDE MAPPING SYSTEM
K964689 · Accumed Intl., Inc.
JOY · Device, Automated Cell-locating · 269d
Cleared Aug 13, 1997
REAADS VON WILLEBRAND FACTOR ANTIGEN TEST KIT
K972005 · Reaads Medical Products, Inc.
GGP · Test, Qualitative And Quantitative Factor Deficiency · 75d
Cleared Aug 13, 1997
REAADS PROTEIN S ANTIGEN TEST KIT
K972482 · Reaads Medical Products, Inc.
GGP · Test, Qualitative And Quantitative Factor Deficiency · 42d
Cleared Aug 13, 1997
PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR V DEFICIENT PLASMA (THROMBOSDREEN BRAND) (100056)
K972627 · Pacific Hemostasis
GJT · Plasma, Coagulation Factor Deficient · 30d
Cleared Aug 12, 1997
ABBOTT CELL-DYN 4000 IMMATURE RETICULOCYTE FRACTION (IRF)
K971152 · Abbott Laboratories
GKZ · Counter, Differential Cell · 137d
Cleared Aug 12, 1997
SPECTROLYSE HEPARIN (ANTI-IIA)
K972209 · Medical Diagnostic Technologies, Inc.
KFF · Assay, Heparin · 62d
Cleared Aug 06, 1997
VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM
K972609 · Bio-Rad
LCQ · Fluorescent Immunoassay Gentamicin · 26d
Cleared Jul 25, 1997
VON WILLEBRAND REAGENT
K972116 · Behring Diagnostics, Inc.
GGP · Test, Qualitative And Quantitative Factor Deficiency · 50d
Cleared Jul 25, 1997
SIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBIN III
K972144 · Sigma Diagnostics, Inc.
JBQ · Antithrombin Iii Quantitation · 49d
Cleared Jul 24, 1997
ESR CONTROL-HC HEMATOLOGY ERYTHROCYTE SEDIMENTATION
K972170 · R&D Systems, Inc.
JPK · Mixture, Hematology Quality Control · 45d
Cleared Jul 24, 1997
ESR CONTROL-M HEMATOLOGY ERYTHROCYTE SEDIMENTATION
K972172 · R&D Systems, Inc.
JPK · Mixture, Hematology Quality Control · 45d
Cleared Jul 22, 1997
CRYO CHECK FACTOR V DEFICIENT PLASMA
K971223 · Precision Biologicals, Inc.
GJT · Plasma, Coagulation Factor Deficient · 111d
Cleared Jul 18, 1997
CRYO CHECK FACTOR IX DEFICIENT PLASMA
K971226 · Precision Biologicals, Inc.
GJT · Plasma, Coagulation Factor Deficient · 107d
Cleared Jul 18, 1997
CRYO CHECK FACTOR X DEFICIENT PLASMA
K971227 · Precision Biologicals, Inc.
GJT · Plasma, Coagulation Factor Deficient · 107d
Cleared Jul 17, 1997
CRYO CHECK FACTOR VII DEFICIENT PLASMA
K971224 · Precision Biologicals, Inc.
GJT · Plasma, Coagulation Factor Deficient · 106d
Cleared Jul 17, 1997
CRYO CHECK FACTOR VIII DEFICIENT PLASMA
K971225 · Precision Biologicals, Inc.
GJT · Plasma, Coagulation Factor Deficient · 106d
Cleared Jul 14, 1997
ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATE
K951459 · Ortho Diagnostic Systems, Inc.
GKZ · Counter, Differential Cell · 837d
Cleared Jul 14, 1997
FACTOR DEFICIENT PLASMAS - FACTOR XI (11)
K972286 · Universal Reagents, Inc.
GJT · Plasma, Coagulation Factor Deficient · 25d
Cleared Jul 14, 1997
FACTOR DEFICIENT PLASMAS - FACTOR IX (9)
K972288 · Universal Reagents, Inc.
GGP · Test, Qualitative And Quantitative Factor Deficiency · 25d
Cleared Jun 30, 1997
COULTER ACT TRON CELL CONTROL
K971469 · Coulter Corp.
JPK · Mixture, Hematology Quality Control · 69d
Cleared Jun 26, 1997
STA LIATEST CONTROL [N]+[P] KIT
K964716 · American Bioproducts Co.
GGN · Plasma, Coagulation Control · 213d

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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 GKL Counter, Cell, Automated (particle Counter) 97 LCP Assay, Glycosylated Hemoglobin 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