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.

3293
Total
3286
Cleared
158d
Avg (2y)
1976
Since
1855 Hematology devices
426–450 of 1855
Cleared May 29, 2001
TINA-QUANT D-DIMER TEST SYSTEM
K011143 · Roche Diagnostics Corp.
GHH · Fibrin Split Products · 46d
Cleared May 18, 2001
K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT
K002948 · Kamiya Biomedical Co.
DAP · Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control · 239d
Cleared May 15, 2001
RUBICON PROTHROMBIN TIME MONITORING SYSTEM
K001699 · Lifescan, Inc.
GJS · Test, Time, Prothrombin · 347d
Cleared May 11, 2001
R & D 4K RETIC
K010470 · R&D Systems, Inc.
JPK · Mixture, Hematology Quality Control · 80d
Cleared May 01, 2001
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
K010494 · Dade Behring, Inc.
JPA · System, Multipurpose For In Vitro Coagulation Studies · 70d
Cleared Apr 13, 2001
IL TEST FREE PROTEIN S
K010379 · Instrumentation Laboratory CO
GGP · Test, Qualitative And Quantitative Factor Deficiency · 64d
Cleared Apr 13, 2001
COULTER HMX ANALYZER, MODEL 6605523, COULTER HMX WITH AUTOLOADER, MODEL 6605526
K010765 · Beckman Coulter, Inc.
GKZ · Counter, Differential Cell · 30d
Cleared Apr 03, 2001
ADVIA RETIC PLUS
K010461 · R&D Systems, Inc.
JPK · Mixture, Hematology Quality Control · 46d
Cleared Mar 23, 2001
SYNOVIALSCOPICS, SYNOVIAL FLUID CONTROL
K010598 · Quantimetrix Corp.
JPK · Mixture, Hematology Quality Control · 23d
Cleared Mar 22, 2001
THROMBOMAX-HS WITH CALCIUM, MODEL T6540
K010158 · Sigma Diagnostics, Inc.
GGO · Reagent, Thromboplastin And Control · 64d
Cleared Mar 16, 2001
ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON COBAS INTEGRA
K002706 · Roche Diagnostics Corp.
DAP · Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control · 198d
Cleared Mar 16, 2001
CBC-SF
K010409 · R&D Systems, Inc.
JPK · Mixture, Hematology Quality Control · 32d
Cleared Mar 15, 2001
SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A
K003267 · Sigma Diagnostics, Inc.
DAP · Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control · 148d
Cleared Mar 01, 2001
ACCUCLOT CONTROL I, MODEL A4089
K003328 · Sigma Diagnostics, Inc.
GIZ · Plasma, Control, Normal · 128d
Cleared Mar 01, 2001
SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217
K003329 · Sigma Diagnostics, Inc.
GGC · Control, Plasma, Abnormal · 128d
Cleared Feb 20, 2001
THROMBOREL S
K003870 · Dade Behring, Inc.
GJS · Test, Time, Prothrombin · 67d
Cleared Feb 07, 2001
4C-ES CELL, MODELS 7547187, 7547188, 7547189, 7547190
K010064 · Beckman Coulter, Inc.
JPK · Mixture, Hematology Quality Control · 30d
Cleared Feb 07, 2001
5C-ES CELL CONTROL, MODELS 7547191, 7547192
K010066 · Beckman Coulter, Inc.
JPK · Mixture, Hematology Quality Control · 30d
Cleared Feb 05, 2001
ADVIA 120 HEMATOLOGY
K003796 · Bayer Corp.
GKZ · Counter, Differential Cell · 59d
Cleared Jan 16, 2001
CD-CAL PLUS CALIBRATOR
K003991 · R&D Systems, Inc.
KRX · Calibrator For Cell Indices · 21d
Cleared Jan 12, 2001
CBC-4K HEMATOLOGY CONTROL
K003874 · R&D Systems, Inc.
JPK · Mixture, Hematology Quality Control · 28d
Cleared Dec 19, 2000
VARIANT II TOTAL GHB
K003280 · Bio-Rad
LCP · Assay, Glycosylated Hemoglobin · 61d
Cleared Dec 18, 2000
MODIFICATION TO INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN A1C
K003120 · Roche Diagnostics Corp.
LCP · Assay, Glycosylated Hemoglobin · 74d
Cleared Dec 01, 2000
PENTRA 5D
K003534 · R&D Systems, Inc.
JPK · Mixture, Hematology Quality Control · 15d
Cleared Nov 29, 2000
LYPHOCHEK HEMOGLOBIN ALC LINEARITY SET
K003030 · Bio-Rad
GGM · Control, Hemoglobin · 62d

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All categories 1855 GKZ Counter, Differential Cell 192 JPK Mixture, Hematology Quality Control 133 GGP Test, Qualitative And Quantitative Factor Deficiency 127 JPA System, Multipurpose For In Vitro Coagulation Studies 116 GJS Test, Time, Prothrombin 93 LCP Assay, Glycosylated Hemoglobin 72 GJT Plasma, Coagulation Factor Deficient 61 GGN Plasma, Coagulation Control 56 GKL Counter, Cell, Automated (particle Counter) 52 DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control 42 GFO Activated Partial Thromboplastin 37 GKP Instrument, Coagulation, Automated 37 JBQ Antithrombin Iii Quantitation 34 GGC Control, Plasma, Abnormal 29 KFF Assay, Heparin 29