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
476–500 of 1855
Cleared Mar 03, 2000
CELL-CHEX
K000076 · Streck Laboratories, Inc.
GJR · Control, Red-cell · 53d
Cleared Mar 03, 2000
FIBRINOGEN CALIBRATOR KIT
K994341 · Dade Behring, Inc.
GFX · Fibrinogen Standard · 71d
Cleared Jan 28, 2000
ADVANCED D-DIMER
K992957 · Dade Behring, Inc.
DAP · Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control · 148d
Cleared Jan 14, 2000
ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYSTEM
K992851 · Roche Diagnostics Corp.
JBP · Activated Whole Blood Clotting Time · 143d
Cleared Jan 14, 2000
XE CHECK
K994388 · Streck Laboratories, Inc.
GLQ · Mixture, Control, White-cell And Red-cell Indices · 17d
Cleared Jan 11, 2000
BEHRING COAGULATION SYSTEM (BCS)
K992959 · Dade Behring, Inc.
JPA · System, Multipurpose For In Vitro Coagulation Studies · 131d
Cleared Dec 07, 1999
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
K993299 · Dade Behring, Inc.
GKP · Instrument, Coagulation, Automated · 67d
Cleared Dec 06, 1999
SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094
K992711 · Sigma Diagnostics, Inc.
GFO · Activated Partial Thromboplastin · 117d
Cleared Dec 06, 1999
SIGMA DIAGNOSTICS ALEXIN LS, MODELS A1219, A1334
K992712 · Sigma Diagnostics, Inc.
GFO · Activated Partial Thromboplastin · 117d
Cleared Dec 06, 1999
K-ASSAY FIBRINOGEN
K993482 · Kamiya Biomedical Co.
GIS · Test, Fibrinogen · 53d
Cleared Dec 02, 1999
STAT PROFILE PHOX CO-OXIMETER ANALYZER, NOVA CO-OXIMETER CONTROLS, LEVELS 1 AND 2, NOVA CO-OXIMETER THB CALIBRATOR
K993104 · Nova Biomedical Corp.
GLY · Oximeter To Measure Hemoglobin · 77d
Cleared Nov 30, 1999
PARA TECH PLUS RETICS
K993825 · Streck Laboratories, Inc.
JCN · Control, Cell Counter, Normal And Abnormal · 18d
Cleared Nov 26, 1999
CD-CHEX CD 34
K993126 · Streck Laboratories, Inc.
GGL · Control, White-cell · 67d
Cleared Nov 22, 1999
CASCADE LIQUID COAGULATION CONTROL LEVELS 1, 2, AND 3
K992829 · Medical Analysis Systems, Inc.
GGN · Plasma, Coagulation Control · 91d
Cleared Nov 22, 1999
STAK-CHEX PLUS RETICS
K992887 · Streck Laboratories, Inc.
GLQ · Mixture, Control, White-cell And Red-cell Indices · 87d
Cleared Nov 12, 1999
R&D HGB/GLC WHOLE BLOOD CONTROL
K993321 · R&D Systems, Inc.
GGM · Control, Hemoglobin · 39d
Cleared Nov 09, 1999
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000
K993174 · Dade Behring, Inc.
GKP · Instrument, Coagulation, Automated · 48d
Cleared Nov 02, 1999
PTN TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, PTN CONTROLS FOR COAGUCHEK PRO SYSTEM
K992492 · Roche Diagnostics Corp.
GJS · Test, Time, Prothrombin · 99d
Cleared Nov 01, 1999
ABBOTT ARCHITECT GLYCATED HEMOGLOBIN
K991483 · Abbott Laboratories
LCP · Assay, Glycosylated Hemoglobin · 187d
Cleared Nov 01, 1999
IL TEST VON WILLEBRAND FACTOR
K992704 · Instrumentation Laboratory CO
GGP · Test, Qualitative And Quantitative Factor Deficiency · 81d
Cleared Sep 24, 1999
MODIFICATION OF: CELL-DYN 1200 SYSTEM
K992444 · Abbott Laboratories
GKZ · Counter, Differential Cell · 64d
Cleared Sep 23, 1999
QBC STAR CENTRIFUGAL HEMATOLOGY SYSTEM
K992849 · Bd Becton Dickinson Vacutainer Systems Preanalytic
GKZ · Counter, Differential Cell · 30d
Cleared Sep 21, 1999
ACID HEMOGLOBIN KIT
K992199 · Helena Laboratories
JBD · System, Analysis, Electrophoretic Hemoglobin · 83d
Cleared Sep 21, 1999
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500
K992423 · Dade Behring, Inc.
GKP · Instrument, Coagulation, Automated · 62d
Cleared Sep 21, 1999
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-500
K992763 · Dade Behring, Inc.
GKP · Instrument, Coagulation, Automated · 35d

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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