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
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
Dec 22, 2004
HEMOSIL RECOMBIPLASTIN
GJS
Test, Time, Prothrombin
35d
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 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 21, 2004
CONTROL PLASMA N AND CONTROL PLASMA P
GGN
Plasma, Coagulation Control
66d
Cleared
Oct 19, 2004
RETIC-CHEX FOR CELL-DYN
JPK
Mixture, Hematology Quality Control
27d
Cleared
Oct 18, 2004
HEPARINASE HR ACT CONTROL, MODEL 550-12
GGN
Plasma, Coagulation Control
68d
Cleared
Oct 18, 2004
PURPLE/BLACK HEPARIN ASSAY CONTROL
GGN
Plasma, Coagulation Control
63d
Cleared
Oct 14, 2004
METER TRAX TRILEVEL, LOW LEVEL, MID LEVEL, HIGH LEVEL TRILEVEL MINIPAK
JPK
Mixture, Hematology Quality Control
45d
Cleared
Oct 12, 2004
COULTER A T 5DIFF CAP PIERCE (CP)
GKZ
Counter, Differential Cell
62d
Cleared
Oct 01, 2004
HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20
JOX
Analyzer, Heparin, Automated
60d
Cleared
Sep 28, 2004
HEMOSIL CALIBRATION PLASMA
JIX
Calibrator, Multi-analyte Mixture
75d
Cleared
Sep 17, 2004
BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM
GKZ
Counter, Differential Cell
28d
Cleared
Sep 01, 2004
ROCHE DIAGNOSTICS CARDIAC D-DIMER RAPID ASSAY
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
302d
Cleared
Sep 01, 2004
R&D CBC-XE HEMATOLOGY CONTROL
JPK
Mixture, Hematology Quality Control
29d
Cleared
Aug 11, 2004
ADVANCED D-DIMER ASSAY
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
71d
Cleared
Jul 27, 2004
CYTO-CHEX BCT
JKA
Tubes, Vials, Systems, Serum Separators, Blood Collection
189d
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