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
Mar 17, 2005
BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA
GGN
Plasma, Coagulation Control
93d
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
Cleared
Feb 09, 2005
HEMOSIL FACTOR XII DEFICIENT PLASMA
GJT
Plasma, Coagulation Factor Deficient
56d
Cleared
Jan 19, 2005
FLOWCARE PLG CD4 REAGENT
GKZ
Counter, Differential Cell
61d
Cleared
Jan 10, 2005
CYTOVISION FOR CEP XY
NTH
System, Automated Scanning Microscope And Image Analysis For Fluorescence In Situ Hybridization (fish) Assays
112d
Cleared
Dec 22, 2004
PEFAKIT APC-R FACTOR V LEIDEN CONTROLS
GGN
Plasma, Coagulation Control
78d
Cleared
Dec 22, 2004
PEFAKIT APC-R FACTOR V LEIDEN
GGW
Test, Time, Partial Thromboplastin
78d
Cleared
Dec 22, 2004
HEMOSIL RECOMBIPLASTIN
GJS
Test, Time, Prothrombin
35d
Cleared
Dec 15, 2004
ANEMIAPRO SELF-SCREENER
KHG
Whole Blood Hemoglobin Determination
105d
Cleared
Dec 10, 2004
ENZYGNOST F+2 (MONOCLONAL) TEST KIT
MIF
Prothrombin Fragment 1.2
72d
Cleared
Dec 03, 2004
HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR
JOX
Analyzer, Heparin, Automated
25d
Cleared
Dec 02, 2004
COATEST SP FVIII
GGP
Test, Qualitative And Quantitative Factor Deficiency
71d
Cleared
Dec 02, 2004
DADE BEHRING HEPARIN CALIBRATOR AND CONTROLS
GIZ
Plasma, Control, Normal
38d
Cleared
Dec 01, 2004
CONTROL PLASMA N, PROC CONTROL PLASMA
GGN
Plasma, Coagulation Control
93d
Cleared
Nov 29, 2004
TRIAGE D-DIMER TEST, MODEL 98100
GHH
Fibrin Split Products
41d
Cleared
Nov 29, 2004
FIBROTEK FIB
GIS
Test, Fibrinogen
38d
Cleared
Nov 23, 2004
FLOWCARE SYSTEM
GKZ
Counter, Differential Cell
134d
Cleared
Nov 19, 2004
COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM
JQC
Centrifuges (micro, Ultra, Refrigerated) For Clinical Use
67d
Cleared
Nov 05, 2004
LIQUICHEK RETICULOCYTE CONTROL (A)
JPK
Mixture, Hematology Quality Control
22d
Cleared
Oct 29, 2004
MODIFICATION TO COULTER LH 500 HEMATOLOGY ANALYZER
GKZ
Counter, Differential Cell
28d
Cleared
Oct 29, 2004
QC-BEADS
NRF
Material, Quality Control, Semen Analysis
25d
Cleared
Oct 21, 2004
POLYMEDCO OC AUTO MICRO 80 FOB TEST
OOX
Automated Occult Blood Analyzer
147d
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