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
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 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 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 01, 2004
ROCHE DIAGNOSTICS CARDIAC D-DIMER RAPID ASSAY
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
302d
Cleared
Aug 11, 2004
ADVANCED D-DIMER ASSAY
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
71d
Cleared
Jun 28, 2004
LIQUICHEK HEMATOLOGY CONTROL (A)
JPK
Mixture, Hematology Quality Control
27d
Cleared
Jun 10, 2004
VIDAS D-DIMER EXCLUSION ASSAY, MODEL 30 442
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
66d
Cleared
Apr 30, 2004
HEMOSIL VON WILLEBRAND ACTIVITY
GGP
Test, Qualitative And Quantitative Factor Deficiency
29d
Cleared
Mar 19, 2004
HEMOSIL SPECIAL TEST CONTROLS LEVEL 1 & 2
JPA
System, Multipurpose For In Vitro Coagulation Studies
35d
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
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
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 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
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