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
Aug 19, 1997
ASSERACHROM TPA TEST KIT
GGP
Test, Qualitative And Quantitative Factor Deficiency
116d
Cleared
Aug 12, 1997
ABBOTT CELL-DYN 4000 IMMATURE RETICULOCYTE FRACTION (IRF)
GKZ
Counter, Differential Cell
137d
Cleared
Aug 12, 1997
SPECTROLYSE HEPARIN (ANTI-IIA)
KFF
Assay, Heparin
62d
Cleared
Aug 06, 1997
VARIANT EXPRESS GLYCOHEMOGLOBIN PROGRAM
LCQ
Fluorescent Immunoassay Gentamicin
26d
Cleared
Jul 25, 1997
VON WILLEBRAND REAGENT
GGP
Test, Qualitative And Quantitative Factor Deficiency
50d
Cleared
Jul 25, 1997
SIGMA DIAGNOSTICS ACCUCOLOR ANTITHROMBIN III
JBQ
Antithrombin Iii Quantitation
49d
Cleared
Jul 24, 1997
ESR CONTROL-HC HEMATOLOGY ERYTHROCYTE SEDIMENTATION
JPK
Mixture, Hematology Quality Control
45d
Cleared
Jul 24, 1997
ESR CONTROL-M HEMATOLOGY ERYTHROCYTE SEDIMENTATION
JPK
Mixture, Hematology Quality Control
45d
Cleared
Jul 14, 1997
ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATE
GKZ
Counter, Differential Cell
837d
Cleared
Jun 30, 1997
COULTER ACT TRON CELL CONTROL
JPK
Mixture, Hematology Quality Control
69d
Cleared
Jun 26, 1997
STA LIATEST CONTROL [N]+[P] KIT
GGN
Plasma, Coagulation Control
213d
Cleared
Jun 26, 1997
STA-LIATEST D-DI TEST KIT
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
213d
Cleared
Jun 24, 1997
MOUSE ANTI-HUMAN CD45, LEUCOCYTE COMMON ANTIGEN (LCA)/FITC AND CD14, MONOCYTE/RPE
GKZ
Counter, Differential Cell
194d
Cleared
May 23, 1997
STA D-DI CALIBRATOR KIT
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
179d
Cleared
May 19, 1997
BC THROMBIN REAGENT
GJA
Test, Thrombin Time
88d
Cleared
May 05, 1997
BEHRING COAGULATION SYSTEM
JPA
System, Multipurpose For In Vitro Coagulation Studies
90d
Cleared
Apr 22, 1997
COAGUCHEK PST SYSTEM
GJS
Test, Time, Prothrombin
295d
Cleared
Apr 21, 1997
HUMAN PROTEIN S RID TEST KIT
GGP
Test, Qualitative And Quantitative Factor Deficiency
742d
Cleared
Apr 16, 1997
CBC-4K HEMATOLOGY CONTROL
JPK
Mixture, Hematology Quality Control
78d
Cleared
Mar 28, 1997
GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEM
JQW
Station, Pipetting And Diluting, For Clinical Use
260d
Cleared
Mar 18, 1997
THROMBONOSTIKA F1.2
MIF
Prothrombin Fragment 1.2
99d
Cleared
Mar 18, 1997
MDA HEPARIN ANTI-X ASSAY
KFF
Assay, Heparin
89d
Cleared
Mar 12, 1997
PROTIME MICROCOAGULATION SYSTEM
GJS
Test, Time, Prothrombin
303d
Cleared
Mar 07, 1997
SPECKTIN-LA TEST SET
GFO
Activated Partial Thromboplastin
295d
Cleared
Mar 06, 1997
ORTHO-MUNE OK-COMBO CONTROL IGG2A-FITC/IGG2A-PE MONOCLONAL ANTIBODY (MURINE)
GKZ
Counter, Differential Cell
699d
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