FDA 510(k) Hematology Devices
About Hematology Devices
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.
3291
Total
3284
Cleared
113d
Avg days
1976
Since
97 Hematology devices
Cleared
Feb 27, 2025
microINR System
GJS
Test, Time, Prothrombin
104d
Cleared
Feb 21, 2025
Xpert® FII & FV
NPR
Test, Factor Ii G20210a Mutations, Genomic Dna Pcr
28d
Cleared
Feb 20, 2025
Alinity h-series System
GKZ
Counter, Differential Cell
126d
Cleared
Feb 03, 2025
Cito CBC System
GKZ
Counter, Differential Cell
360d
Cleared
Jan 28, 2025
HemosIL CL HIT-IgG(PF4-H)
LCO
Platelet Factor 4 Radioimmunoassay
90d
Cleared
Jan 15, 2025
TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge
JPA
System, Multipurpose For In Vitro Coagulation Studies
30d
Cleared
Nov 29, 2024
YO Home Sperm Test
POV
Semen Analysis Device
176d
Cleared
Oct 31, 2024
BD Vacutainer® Citrate Blood Collection Tubes
GIM
Tubes, Vacuum Sample, With Anticoagulant
259d
Cleared
Oct 10, 2024
INNOVANCE Anti-Xa (OPPU05)
QLU
Anti-factor Xa Activity Test System, Apixaban
251d
Cleared
Aug 16, 2024
ACL TOP Family 50 Series (ACL TOP 750
GKP
Instrument, Coagulation, Automated
28d
Cleared
Jul 05, 2024
UniCel DxH 900 Coulter Cellular Analysis System
GKZ
Counter, Differential Cell
157d
Cleared
May 21, 2024
Yumizen H2500
GKZ
Counter, Differential Cell
244d
Cleared
May 02, 2024
HemoScreen Hematology Analyzer
GKZ
Counter, Differential Cell
57d
Cleared
Apr 22, 2024
Access EPO
GGT
Assay, Erythropoietin
90d
Cleared
Apr 04, 2024
CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS Instrument
GKA
Abnormal Hemoglobin Quantitation
272d
Cleared
Mar 29, 2024
Citrated: K, KH, RTH, FFH
JPA
System, Multipurpose For In Vitro Coagulation Studies
266d
Cleared
Mar 27, 2024
QStat Cartridge
QFR
Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties
82d
Not Cleared
Mar 22, 2024
X100 with Full Field Bone Marrow Aspirate (BMA) Application 2 X100HT with Full Field Bone Marrow Aspirate (BMA) Application
SAL
Device, Automated Cell Locating, Bone Marrow
329d
Cleared
Mar 15, 2024
Xprecia Prime Coagulation System
GJS
Test, Time, Prothrombin
358d
Not Cleared
Feb 28, 2024
Technozym ADAMTS13 Activity
SAC
Adamts13 Activity Test System
328d
Cleared
Dec 21, 2023
Sysmex XQ-Series (XQ-320) Automated Hematology Analyzer
GKZ
Counter, Differential Cell
265d
Cleared
Nov 27, 2023
BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube
GIM
Tubes, Vacuum Sample, With Anticoagulant
277d
Cleared
Sep 29, 2023
ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgM
JPA
System, Multipurpose For In Vitro Coagulation Studies
506d
Cleared
Aug 25, 2023
BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes
GIM
Tubes, Vacuum Sample, With Anticoagulant
641d
Cleared
Aug 04, 2023
Alinity h-series System
GKZ
Counter, Differential Cell
576d
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