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.
3297
Total
3290
Cleared
164d
Avg (2y)
1976
Since
3297 Hematology devices
Cleared
May 26, 2011
CELL-CHEX WITH CPPD CRYSTALS
GLQ
Mixture, Control, White-cell And Red-cell Indices
72d
Cleared
May 16, 2011
STRATUS CS ACUTE CARE D-DIMER
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
104d
Cleared
Apr 28, 2011
R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL
JPK
Mixture, Hematology Quality Control
325d
Cleared
Apr 05, 2011
HEMOSIL LA POSITIVE CONTROL
GGC
Control, Plasma, Abnormal
210d
Cleared
Mar 17, 2011
HEMOSIL PROTEIN S ACTIVITY ASSAY
GGP
Test, Qualitative And Quantitative Factor Deficiency
227d
Cleared
Mar 07, 2011
BD FACS SAMPLE PREP ASSISTANT III (SPA III)
GKZ
Counter, Differential Cell
227d
Cleared
Mar 04, 2011
EKF- DIAGNOSTIC HEMO_CONTROL HEMOGLOBIN MEASUREMENT SYSTEM
GKR
System, Hemoglobin, Automated
21d
Cleared
Jan 28, 2011
HEMA SCREEN ER
KHE
Reagent, Occult Blood
135d
Cleared
Dec 30, 2010
LUPOTEK KCT
GGW
Test, Time, Partial Thromboplastin
714d
Cleared
Dec 21, 2010
COULTER LIN-X LINEARITY CONTROL, MODEL A81196
JPK
Mixture, Hematology Quality Control
274d
Cleared
Dec 20, 2010
PT-MULTI-CALIBRATOR, MODEL OPAT07
GGN
Plasma, Coagulation Control
369d
Cleared
Dec 15, 2010
SPECIALTY ASSAYED CONTROL-2
GGC
Control, Plasma, Abnormal
336d
Cleared
Dec 06, 2010
SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM
JQC
Centrifuges (micro, Ultra, Refrigerated) For Clinical Use
21d
Cleared
Dec 03, 2010
CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL
GGN
Plasma, Coagulation Control
23d
Cleared
Dec 01, 2010
HEPARIN ASSAY CONTROLS
GGN
Plasma, Coagulation Control
21d
Cleared
Nov 29, 2010
INNOVANCE D-DIMER, MODEL OPBP09
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
370d
Cleared
Nov 18, 2010
COULTER 4C-EX 300 CELL CONTROL
JPK
Mixture, Hematology Quality Control
260d
Cleared
Nov 04, 2010
HEPARIN DOSE RESPONSE CARTRIDGE
JOX
Analyzer, Heparin, Automated
31d
Cleared
Oct 26, 2010
DXH 300 COULTER CELLULAR ANALYSIS SYSTEM, DXH 300C COULTER CELLULAR ANALYSSI SYSTEM MODEL: 71772, 71771
GKZ
Counter, Differential Cell
249d
Cleared
Oct 18, 2010
IMMUKNOW-THE CYLEX IMMUNE CELLFUNCTION ASSAY
NID
Assay, Proliferation, In Vitro, T Lymphocyte
101d
Cleared
Oct 13, 2010
HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX
JOX
Analyzer, Heparin, Automated
160d
Cleared
Oct 01, 2010
ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800
OSL
Control, Fecal Occult Blood
92d
Cleared
Aug 31, 2010
IQ 200 URINE ANALIZER BODY FLUIDS MODULE
GKL
Counter, Cell, Automated (particle Counter)
462d
Cleared
Aug 26, 2010
CELLTRACKS AUTOPREP SYSTEM MODEL:9541
GKH
Apparatus, Automated Blood Cell Diluting
169d
Cleared
Aug 23, 2010
CELL-CHEX
GLQ
Mixture, Control, White-cell And Red-cell Indices
103d
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