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
2616 Hematology devices
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
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 06, 2004
VERIFYNOW-ASPIRIN ASSAY
JOZ
System, Automated Platelet Aggregation
29d
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
BD FACSCANTO WITH BD FACSANTO SOFTWARE
GKZ
Counter, Differential Cell
144d
Cleared
Sep 17, 2004
BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM
GKZ
Counter, Differential Cell
28d
Cleared
Sep 10, 2004
BD FACS 7-COLOR SETUP BEADS
GKZ
Counter, Differential Cell
247d
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