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
Cleared
May 10, 2006
ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP
JPA
System, Multipurpose For In Vitro Coagulation Studies
27d
Cleared
May 02, 2006
HEMOSIL PT-FIBRINOGEN HS PLUS
GJS
Test, Time, Prothrombin
27d
Cleared
Apr 13, 2006
HEMOSIL SYNTHASIL
GFO
Activated Partial Thromboplastin
29d
Cleared
Mar 28, 2006
COULTER 5C CELL CONTROL
JPK
Mixture, Hematology Quality Control
34d
Cleared
Feb 21, 2006
ACL ELITE
JPA
System, Multipurpose For In Vitro Coagulation Studies
29d
Cleared
Jan 13, 2006
HEMOSIL PROS
GGP
Test, Qualitative And Quantitative Factor Deficiency
28d
Cleared
Dec 23, 2005
COAG-A-MATE MTX III
JPA
System, Multipurpose For In Vitro Coagulation Studies
245d
Cleared
Dec 07, 2005
MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM
GKL
Counter, Cell, Automated (particle Counter)
167d
Cleared
Nov 18, 2005
MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER
GKZ
Counter, Differential Cell
35d
Cleared
Aug 17, 2005
STRATUS CS D-DIMER
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
62d
Cleared
Aug 01, 2005
ITAG MHC TETRAMER CMV ASSAY
GKZ
Counter, Differential Cell
91d
Cleared
Jul 21, 2005
CELL-DYN SAPPHIRE SYSTEM
GKZ
Counter, Differential Cell
70d
Cleared
Jul 12, 2005
R&D CBC-4K PLUS RETICS HEMATOLOGY CONTROL
JPK
Mixture, Hematology Quality Control
50d
Cleared
Jul 11, 2005
HEMORAM/AGGRAM ANALYZER
JPA
System, Multipurpose For In Vitro Coagulation Studies
182d
Cleared
Jun 29, 2005
TRIAGE(R) D-DIMER CALIBRATION VERIFICATION CONTROLS
GGN
Plasma, Coagulation Control
91d
Cleared
Jun 29, 2005
DADE THROMBIN REAGENT
KQJ
System, Fibrinogen Determination
76d
Cleared
May 12, 2005
BIO-RAD VARIANT NBS SICKLE CELL PROGRAM
GKA
Abnormal Hemoglobin Quantitation
16d
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 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 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
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