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
2617 Hematology devices
Cleared
Jun 21, 2001
DADE PFA-100 PLATELET FUNCTION ANALYZER MODEL-100, DADE PFA COLLEGEN/EPINEPHRINE TEST CARTRIDE, DADE PFA COLLEAGEN /ADP
JOZ
System, Automated Platelet Aggregation
279d
Cleared
Jun 06, 2001
HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS
KFF
Assay, Heparin
135d
Cleared
Jun 06, 2001
CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAY
GKZ
Counter, Differential Cell
68d
Cleared
Jun 06, 2001
STA-LIATEST FREE PROTEIN S TEST KIT
GGP
Test, Qualitative And Quantitative Factor Deficiency
68d
Cleared
May 29, 2001
TINA-QUANT D-DIMER TEST SYSTEM
GHH
Fibrin Split Products
46d
Cleared
May 18, 2001
K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
239d
Cleared
May 15, 2001
RUBICON PROTHROMBIN TIME MONITORING SYSTEM
GJS
Test, Time, Prothrombin
347d
Cleared
May 11, 2001
R & D 4K RETIC
JPK
Mixture, Hematology Quality Control
80d
Cleared
May 01, 2001
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
JPA
System, Multipurpose For In Vitro Coagulation Studies
70d
Cleared
Apr 13, 2001
IL TEST FREE PROTEIN S
GGP
Test, Qualitative And Quantitative Factor Deficiency
64d
Cleared
Apr 13, 2001
COULTER HMX ANALYZER, MODEL 6605523, COULTER HMX WITH AUTOLOADER, MODEL 6605526
GKZ
Counter, Differential Cell
30d
Cleared
Apr 09, 2001
STA-QUALITY HBPM/LMWH KIT
GGN
Plasma, Coagulation Control
66d
Cleared
Apr 09, 2001
STA -CALIBRATOR HBPM/LMWH KIT
GGN
Plasma, Coagulation Control
63d
Cleared
Apr 03, 2001
ADVIA RETIC PLUS
JPK
Mixture, Hematology Quality Control
46d
Cleared
Mar 23, 2001
SYNOVIALSCOPICS, SYNOVIAL FLUID CONTROL
JPK
Mixture, Hematology Quality Control
23d
Cleared
Mar 22, 2001
THROMBOMAX-HS WITH CALCIUM, MODEL T6540
GGO
Reagent, Thromboplastin And Control
64d
Cleared
Mar 16, 2001
ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON COBAS INTEGRA
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
198d
Cleared
Mar 16, 2001
CBC-SF
JPK
Mixture, Hematology Quality Control
32d
Cleared
Mar 15, 2001
SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
148d
Cleared
Mar 01, 2001
ACCUCLOT CONTROL I, MODEL A4089
GIZ
Plasma, Control, Normal
128d
Cleared
Mar 01, 2001
SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217
GGC
Control, Plasma, Abnormal
128d
Cleared
Feb 20, 2001
THROMBOREL S
GJS
Test, Time, Prothrombin
67d
Cleared
Feb 12, 2001
ASSERACHROM HPIA TEST KIT
LCO
Platelet Factor 4 Radioimmunoassay
68d
Cleared
Feb 07, 2001
4C-ES CELL, MODELS 7547187, 7547188, 7547189, 7547190
JPK
Mixture, Hematology Quality Control
30d
Cleared
Feb 07, 2001
5C-ES CELL CONTROL, MODELS 7547191, 7547192
JPK
Mixture, Hematology Quality Control
30d
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