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.
3292
Total
3285
Cleared
161d
Avg (2y)
1976
Since
773 Hematology devices
Cleared
Apr 13, 2006
HEMOSIL SYNTHASIL
GFO
Activated Partial Thromboplastin
29d
Cleared
Mar 28, 2006
COULTER 5C CELL CONTROL
JPK
Mixture, Hematology Quality Control
34d
Cleared
Feb 21, 2006
ACL ELITE
JPA
System, Multipurpose For In Vitro Coagulation Studies
29d
Cleared
Jan 13, 2006
HEMOSIL PROS
GGP
Test, Qualitative And Quantitative Factor Deficiency
28d
Cleared
Dec 23, 2005
COAG-A-MATE MTX III
JPA
System, Multipurpose For In Vitro Coagulation Studies
245d
Cleared
Nov 18, 2005
MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER
GKZ
Counter, Differential Cell
35d
Cleared
Aug 17, 2005
STRATUS CS D-DIMER
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
62d
Cleared
Aug 01, 2005
ITAG MHC TETRAMER CMV ASSAY
GKZ
Counter, Differential Cell
91d
Cleared
Jul 21, 2005
CELL-DYN SAPPHIRE SYSTEM
GKZ
Counter, Differential Cell
70d
Cleared
Jul 11, 2005
HEMORAM/AGGRAM ANALYZER
JPA
System, Multipurpose For In Vitro Coagulation Studies
182d
Cleared
Jun 29, 2005
DADE THROMBIN REAGENT
KQJ
System, Fibrinogen Determination
76d
Cleared
May 02, 2005
HEMOSIL FACTOR II DEFICIENT PLASMA
GJT
Plasma, Coagulation Factor Deficient
48d
Cleared
Apr 26, 2005
HEMOSIL D-DIMER HS
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
55d
Cleared
Apr 01, 2005
MDA B.30
JPA
System, Multipurpose For In Vitro Coagulation Studies
31d
Cleared
Mar 30, 2005
HEMOSIL SILICA CLOTTING TIME
GFO
Activated Partial Thromboplastin
58d
Cleared
Mar 10, 2005
HEMOSIL D-DIMER
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
31d
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
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
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