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
1051–1075 of 3297
Cleared Sep 22, 1997
QUICK-DRAW CAPILLARY WHOLE BLOOD COLLECTION SYSTEM
K972969 · Innovative Medical Technologies, Inc.
GIO · Tube, Collection, Capillary Blood · 42d
Cleared Sep 16, 1997
MICRO21 WITH CEREBROSPINAL FLUID
K971470 · Triangle Biomedical Sciences, Inc.
JOY · Device, Automated Cell-locating · 147d
Cleared Sep 16, 1997
ABBOTT CELL-DYN 3200 SYSTEM
K972354 · Abbott Laboratories
GKZ · Counter, Differential Cell · 84d
Cleared Sep 09, 1997
OPUS D-DIMER
K972316 · Behring Diagnostics, Inc.
GHH · Fibrin Split Products · 81d
Cleared Sep 05, 1997
EZCHEK/HBA BLOOD COLLECTION KIT
K971919 · Flexsite Diagnostics, Inc.
LCP · Assay, Glycosylated Hemoglobin · 105d
Cleared Aug 29, 1997
CRYO CHECK INR VALIDATION SET
K971219 · Precision Biologicals, Inc.
GGN · Plasma, Coagulation Control · 149d
Cleared Aug 29, 1997
ADVIA 120 HEMATOLOGY SYSTEM, IN VITRO DIAGNOSTIC SYSTEM
K971998 · Bayer Corp.
GKL · Counter, Cell, Automated (particle Counter) · 91d
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

Looking for a specific hematology device? Search by device name, K-number or manufacturer.

Search all Hematology 510(k) devices

Filter by Product Code

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