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
2623 Hematology devices
Cleared
Mar 18, 2004
SYSMEX AUTOMATED HEMATOLOGY ANALYZER, XE-2100 SERIES (XE-2100, XE-2100L)
GKZ
Counter, Differential Cell
64d
Cleared
Feb 27, 2004
LYPHOCHEK HEMOSTASIS CONTROL
GGN
Plasma, Coagulation Control
22d
Cleared
Feb 13, 2004
HEMOSIL FACTOR VIII DEFICIENT PLASMA
GJT
Plasma, Coagulation Factor Deficient
51d
Cleared
Feb 11, 2004
SYSMEX POCH-100I
GKL
Counter, Cell, Automated (particle Counter)
166d
Cleared
Jan 12, 2004
ACL TOP MODEL, TOP
GKP
Instrument, Coagulation, Automated
77d
Cleared
Jan 02, 2004
HEMOSIL LIQUID ANTITHROMBIN XL
JBQ
Antithrombin Iii Quantitation
30d
Cleared
Dec 15, 2003
MODIFICATION TO COATEST FACTOR VIII
GGP
Test, Qualitative And Quantitative Factor Deficiency
26d
Cleared
Oct 24, 2003
QUANTEX D-DIMER
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
80d
Cleared
Oct 24, 2003
STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM
GKR
System, Hemoglobin, Automated
73d
Cleared
Sep 26, 2003
COULTER LH 750 HEMATOLOGY ANALYZER
GKZ
Counter, Differential Cell
59d
Cleared
Sep 17, 2003
LYPHOCHEK COAGULATION CONTROL, LEVEL 4, MODEL 743
GGN
Plasma, Coagulation Control
23d
Cleared
Sep 08, 2003
SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560
GKP
Instrument, Coagulation, Automated
130d
Cleared
Sep 08, 2003
IMMATURE GRANULOCYTE (IG) PARAMETER ON THE SYSMEX MODEL XE-2100 AUTOMATED HEMATOLOGY ANALYZER
GKZ
Counter, Differential Cell
69d
Cleared
Sep 08, 2003
ADVIA 60 HEMATOLOGY ANALYZER
GKZ
Counter, Differential Cell
24d
Cleared
Sep 02, 2003
VIDAS D-DIMER NEW (DD2) ASSAY, MODEL 30 442
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
214d
Cleared
Aug 13, 2003
COULTER LH 500 HEMATOLOGY ANALYZER
GKZ
Counter, Differential Cell
64d
Cleared
Aug 08, 2003
LIQUICHEK D-DIMER CONTROL LEVEL 1, 2 AND 3
GGN
Plasma, Coagulation Control
39d
Cleared
Jul 31, 2003
HEMOSIL FACTOR IX DEFICIENT PLASMA
GJT
Plasma, Coagulation Factor Deficient
48d
Cleared
Jul 24, 2003
COULTER ACT 5DIFF AL HEMATOLOGY ANALYZER
GKZ
Counter, Differential Cell
24d
Cleared
Jul 02, 2003
MICROHEATER
BSB
Warmer, Blood, Non-electromagnetic Radiation
51d
Cleared
Jun 27, 2003
K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
114d
Cleared
Jun 06, 2003
CALIBRATION PLASMA LMW HEPARIN
JIS
Calibrator, Primary
71d
Cleared
Jun 06, 2003
CONTROL PLASMA LMW HEPARIN
GGN
Plasma, Coagulation Control
71d
Cleared
May 22, 2003
COAGUCHEK PT.S TEST FOR PROTHROMBIN TIME SELF-TESTING
GJS
Test, Time, Prothrombin
66d
Cleared
May 21, 2003
TETRACXP SYSTEM (SOFTWARE AND SYSTEM GUIDE)
GKZ
Counter, Differential Cell
68d
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