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
Jan 20, 2006
PF4 ENHANCED SOLID PHASE ELISA
LCO
Platelet Factor 4 Radioimmunoassay
30d
Cleared
Jan 13, 2006
CELL-CHEX AUTO
JPK
Mixture, Hematology Quality Control
42d
Cleared
Jan 13, 2006
HEMOSIL PROS
GGP
Test, Qualitative And Quantitative Factor Deficiency
28d
Cleared
Jan 04, 2006
HEPARIN/PLATELET FACTOR 4 ANTIBODY SERUM PANEL
GGN
Plasma, Coagulation Control
98d
Cleared
Jan 04, 2006
SMARTPREP2 CENTRIFUGE SYSTEM
JQC
Centrifuges (micro, Ultra, Refrigerated) For Clinical Use
78d
Cleared
Dec 29, 2005
ABX MICROS CRP 200, OPTION IM
GKZ
Counter, Differential Cell
31d
Cleared
Dec 27, 2005
BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202
GGP
Test, Qualitative And Quantitative Factor Deficiency
316d
Cleared
Dec 23, 2005
COAG-A-MATE MTX III
JPA
System, Multipurpose For In Vitro Coagulation Studies
245d
Cleared
Dec 23, 2005
BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR
GGN
Plasma, Coagulation Control
203d
Cleared
Dec 22, 2005
CHEMPAQ XBC ANALYZER
GKZ
Counter, Differential Cell
274d
Cleared
Dec 12, 2005
T-TEK
GJA
Test, Thrombin Time
256d
Cleared
Dec 07, 2005
MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM
GKL
Counter, Cell, Automated (particle Counter)
167d
Cleared
Dec 07, 2005
EXTENDSURE HBFASC CONTROL
JCM
Control, Hemoglobin, Abnormal
41d
Cleared
Nov 18, 2005
MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER
GKZ
Counter, Differential Cell
35d
Cleared
Nov 07, 2005
BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102
JBQ
Antithrombin Iii Quantitation
371d
Cleared
Oct 17, 2005
ACTICLOT, MODEL 824
GJS
Test, Time, Prothrombin
73d
Cleared
Oct 14, 2005
CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700
JOZ
System, Automated Platelet Aggregation
252d
Cleared
Oct 13, 2005
BELMONT BUDDY FLUID WARMER
BSB
Warmer, Blood, Non-electromagnetic Radiation
27d
Cleared
Oct 03, 2005
CARE FECAL OCCULT BLOOD TEST, MODEL KT313
KHE
Reagent, Occult Blood
90d
Cleared
Sep 23, 2005
CHROMOPEP PC, CHROMOPEP AT, MODELS 2.5 AND 5
GGP
Test, Qualitative And Quantitative Factor Deficiency
213d
Cleared
Sep 23, 2005
SYSMEX MODEL XE-2100DC AUTOMATED HEMATOLOGY ANALYZER
GKZ
Counter, Differential Cell
113d
Cleared
Aug 31, 2005
MS 4/5 HEMATOLOGY ANALYZER
GKZ
Counter, Differential Cell
194d
Cleared
Aug 17, 2005
STRATUS CS D-DIMER
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
62d
Cleared
Aug 17, 2005
IQ BODY FLUIDS CONTROL
JPK
Mixture, Hematology Quality Control
51d
Cleared
Aug 16, 2005
COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM
KQG
Instrument, Coagulation
138d
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