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
2616 Hematology devices
Cleared
Jun 06, 2005
IMMEDIA PROTHROMBIN TIME SYSTEM
JPA
System, Multipurpose For In Vitro Coagulation Studies
124d
Cleared
Jun 01, 2005
ABX ERYTROL
JPK
Mixture, Hematology Quality Control
72d
Cleared
May 24, 2005
HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR
JOX
Analyzer, Heparin, Automated
29d
Cleared
May 12, 2005
BIO-RAD VARIANT NBS SICKLE CELL PROGRAM
GKA
Abnormal Hemoglobin Quantitation
16d
Cleared
May 05, 2005
HEMONIR TM
GLY
Oximeter To Measure Hemoglobin
122d
Cleared
May 04, 2005
RET-HE PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER
GKZ
Counter, Differential Cell
57d
Cleared
May 02, 2005
HEMOSIL FACTOR II DEFICIENT PLASMA
GJT
Plasma, Coagulation Factor Deficient
48d
Cleared
Apr 26, 2005
HEMOSIL D-DIMER HS
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
55d
Cleared
Apr 26, 2005
ABX PENTRA DX 120: OPTION SPS EVOLUTION
GKZ
Counter, Differential Cell
36d
Cleared
Apr 01, 2005
MDA B.30
JPA
System, Multipurpose For In Vitro Coagulation Studies
31d
Cleared
Mar 30, 2005
HEMOSIL SILICA CLOTTING TIME
GFO
Activated Partial Thromboplastin
58d
Cleared
Mar 23, 2005
IQ 200 URINE ANALYZER BODY FLUIDS MODULE
GKL
Counter, Cell, Automated (particle Counter)
50d
Cleared
Mar 18, 2005
CRYOCHECK CLOT S
GGP
Test, Qualitative And Quantitative Factor Deficiency
81d
Cleared
Mar 17, 2005
BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA
GGN
Plasma, Coagulation Control
93d
Cleared
Mar 10, 2005
HEMOSIL D-DIMER
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
31d
Cleared
Feb 22, 2005
MODIFICATION TO BD FACSCANTO SYSTEM WITH BD FACSCANTO CLINICAL SOFTWARE
PER
Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis
26d
Cleared
Feb 10, 2005
HEMOCHRON SIGNATURE ELITE
JPA
System, Multipurpose For In Vitro Coagulation Studies
37d
Cleared
Feb 10, 2005
COULTER LH 750 HEMATOLOGY ANALYZER
GKZ
Counter, Differential Cell
30d
Cleared
Feb 09, 2005
HEMOSIL FACTOR XII DEFICIENT PLASMA
GJT
Plasma, Coagulation Factor Deficient
56d
Cleared
Jan 19, 2005
FLOWCARE PLG CD4 REAGENT
GKZ
Counter, Differential Cell
61d
Cleared
Jan 10, 2005
CYTOVISION FOR CEP XY
NTH
System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (fish) Assays
112d
Cleared
Dec 22, 2004
PEFAKIT APC-R FACTOR V LEIDEN CONTROLS
GGN
Plasma, Coagulation Control
78d
Cleared
Dec 22, 2004
PEFAKIT APC-R FACTOR V LEIDEN
GGW
Test, Time, Partial Thromboplastin
78d
Cleared
Dec 22, 2004
HEMOSIL RECOMBIPLASTIN
GJS
Test, Time, Prothrombin
35d
Cleared
Dec 15, 2004
ANEMIAPRO SELF-SCREENER
KHG
Whole Blood Hemoglobin Determination
105d
Looking for a specific hematology device? Search by device name, K-number or manufacturer.
Search all Hematology 510(k) devices