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
Sep 10, 2004
BD FACSCANTO SYSTEM
GKZ
Counter, Differential Cell
172d
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
THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY
JOZ
System, Automated Platelet Aggregation
86d
Cleared
Sep 01, 2004
R&D CBC-XE HEMATOLOGY CONTROL
JPK
Mixture, Hematology Quality Control
29d
Cleared
Aug 12, 2004
HEMOSURE ONE-STEP FECAL OCCULT BLOOD TEST
KHE
Reagent, Occult Blood
97d
Cleared
Aug 12, 2004
POLYMEDCO OC LIGHT FOBT TEST
KHE
Reagent, Occult Blood
90d
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
Cleared
Jul 27, 2004
QWIKCHECK-BEADS
NRF
Material, Quality Control, Semen Analysis
43d
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
Jun 10, 2004
CDS HEMATOLOGY CALIBRATOR (CDS CAL)
KRZ
Calibrator For Hemoglobin And Hematocrit Measurement
41d
Cleared
Jun 10, 2004
HEMOCUE HEMOGLOBIN 201DM ANALYZING SYSTEM
GKR
System, Hemoglobin, Automated
31d
Cleared
Jun 02, 2004
SEMEN ANALYSIS QUALITY CONTROL, ASSAYED AND UNASSAYED
NRF
Material, Quality Control, Semen Analysis
22d
Cleared
Apr 30, 2004
HEMOSIL VON WILLEBRAND ACTIVITY
GGP
Test, Qualitative And Quantitative Factor Deficiency
29d
Cleared
Apr 05, 2004
REAADS VON WILLEBRAND FACTOR ACTIVITY TEST KIT, MODEL 10826
GGP
Test, Qualitative And Quantitative Factor Deficiency
269d
Cleared
Apr 02, 2004
CHRONO-LOG WHOLE BLOOD AGGREGOMETER, MODELS 591A AND 592A
JOZ
System, Automated Platelet Aggregation
193d
Cleared
Mar 19, 2004
HEMOSIL SPECIAL TEST CONTROLS LEVEL 1 & 2
JPA
System, Multipurpose For In Vitro Coagulation Studies
35d
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
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