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
1026–1050 of 3297
Cleared Dec 18, 1997
IRMA BLOOD ANALYSIS SYSTEM WITH OPTIONAL LIFESCAN SURESTEP PRO BLOOD GLUCOSE MODULE
K974396 · Diametrics Medical, Inc.
CHL · Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph · 27d
Cleared Dec 01, 1997
TRI TEST REAGENT CD4 FIT C/CD8 PE/CD3 PERCP WITH TRUCOUNT ABSOLUTE COUNT TUBES
K971205 · Becton Dickinson Immunocytometry Systems
GKZ · Counter, Differential Cell · 244d
Cleared Nov 25, 1997
TRITEST REAGENT CD3 FITC/CD16+CD56 PE/CD45 PERCP
K971110 · Becton Dickinson Immunocytometry Systems
GKZ · Counter, Differential Cell · 244d
Cleared Nov 24, 1997
SYNCHRON SYSTEM HEMOGLOBIN ALC REAGENT
K973696 · Beckman Instruments, Inc.
LCP · Assay, Glycosylated Hemoglobin · 59d
Cleared Nov 21, 1997
TRITEST REAGENT CD3 FITC/CD4 PE/CD45 PERCP
K965053 · Becton Dickinson Immunocytometry Systems
GKZ · Counter, Differential Cell · 338d
Cleared Nov 21, 1997
TRITEST REAGENT CD3 FITC/CD8 PE/CD45 PERCP
K970326 · Becton Dickinson Immunocytometry Systems
GKZ · Counter, Differential Cell · 297d
Cleared Nov 20, 1997
HEMOCHRON CITRATE APTT
K972831 · International Technidyne Corp.
GFO · Activated Partial Thromboplastin · 113d
Cleared Nov 17, 1997
DADE PFA-100 PLATELET FUNCTION ANALYZER/PFA COLLAGEN/EPINEPHRINE TEST CARTRIDGE/PFA COLLAGEN/ADP TEST CARTRIDGE/
K970505 · Dade Intl., Inc.
JOZ · System, Automated Platelet Aggregation · 280d
Cleared Nov 07, 1997
MICRO21 WITH WBC ESTIMATE
K973050 · Triangle Biomedical Sciences, Inc.
JOY · Device, Automated Cell-locating · 84d
Cleared Nov 04, 1997
IL TEST D-DIMER
K972696 · Instrumentation Laboratory CO
DAP · Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control · 109d
Cleared Nov 04, 1997
IL TEST APTT-SP
K973306 · Instrumentation Laboratory CO
GFO · Activated Partial Thromboplastin · 62d
Cleared Oct 31, 1997
ACCUCOLOR HIGH CALIBRATOR (A3089)
K973274 · Sigma Diagnostics, Inc.
GIZ · Plasma, Control, Normal · 59d
Cleared Oct 29, 1997
COULTER AC.T DIFF ANALYZER
K973634 · Coulter Corp.
GKZ · Counter, Differential Cell · 35d
Cleared Oct 22, 1997
TRITEST CD3 FITC/CD19 PE/CD45 PERCP REAGENT WITH TRUCOUNT ABSOLUTE COUNT TUBES
K970742 · Becton Dickinson Immunocytometry Systems
GKZ · Counter, Differential Cell · 236d
Cleared Oct 20, 1997
N-ASSAY TIA PLASMINOGEN TEST KIT
K971985 · Crestat Diagnostics, Inc.
GGP · Test, Qualitative And Quantitative Factor Deficiency · 144d
Cleared Oct 20, 1997
N-ASSAY TIA ANTITHROMBIN III TEST KIT
K972257 · Crestat Diagnostics, Inc.
DDQ · Antigen, Antiserum, Control, Antithrombin Iii · 125d
Cleared Oct 20, 1997
CS-400 COAGULATION ANALYZER SYSTEM (A1208)
K972260 · Sigma Diagnostics, Inc.
JPA · System, Multipurpose For In Vitro Coagulation Studies · 125d
Cleared Oct 20, 1997
HEMAPROMPT
K972763 · Aerscher Diagnostics
KHE · Reagent, Occult Blood · 88d
Cleared Oct 10, 1997
SIGMA DIAGNOSTICS THROMBOMAX WITH CALCIUM
K972796 · Sigma Diagnostics, Inc.
GJS · Test, Time, Prothrombin · 74d
Cleared Oct 09, 1997
SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A)
K971858 · Sigma Diagnostics, Inc.
KQJ · System, Fibrinogen Determination · 142d
Cleared Oct 06, 1997
REAADS PROTEIN C ANTIGEN TEST KIT
K972342 · Reaads Medical Products, Inc.
GGP · Test, Qualitative And Quantitative Factor Deficiency · 104d
Cleared Oct 01, 1997
B&D ACTIVATED CLOTTING TIME (ACT) TEST TUBES BD-C101 (DIATOMACEOUS EARTH) AND BD-K101 (KAOLIN)
K971935 · B & D Corp.
JBP · Activated Whole Blood Clotting Time · 127d
Cleared Sep 25, 1997
AUTOMATED MULTI-POINT BLOOD VOLUME ANALYZER
K964406 · Daxor Corporation
JWO · Device, Blood Volume Measuring · 325d
Cleared Sep 25, 1997
A1C 2.2 PLUS - AUTOMATED GLYCOHEMOGLOBIN ANALYZER
K972265 · Tosoh Medics, Inc.
LCP · Assay, Glycosylated Hemoglobin · 100d
Cleared Sep 25, 1997
UNIVERSAL REAGENT FACTOR XII (TWELVE) DEFICIENT PLASMA
K973143 · Universal Reagents, Inc.
GGP · Test, Qualitative And Quantitative Factor Deficiency · 34d

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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