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
Jul 14, 2023
i-STAT PTplus Cartridge with the i-STAT 1 System
GJS
Test, Time, Prothrombin
528d
Cleared
Jun 23, 2023
HemosIL Liquid Anti-Xa
QLU
Anti-factor Xa Activity Test System, Apixaban
254d
Cleared
Jun 02, 2023
vWF Ag
GGP
Test, Qualitative And Quantitative Factor Deficiency
445d
Cleared
Feb 15, 2023
Xpert® FII & FV
NPR
Test, Factor Ii G20210a Mutations, Genomic Dna Pcr
139d
Cleared
Dec 09, 2022
HemosIL von Willebrand Factor Antigen
GGP
Test, Qualitative And Quantitative Factor Deficiency
30d
Cleared
Nov 08, 2022
Sysmex XW-100 Automated Hematology Analyzer
GKZ
Counter, Differential Cell
638d
Cleared
Oct 04, 2022
HemosIL Liquid Anti-Xa
KFF
Assay, Heparin
341d
Cleared
Aug 16, 2022
HemosIL ReadiPlasTin
GJS
Test, Time, Prothrombin
299d
Cleared
Jul 02, 2021
iQ200 System, iChemVELOCITY Automated Urine Chemistry System
LKM
Counter, Urine Particle
164d
Cleared
Nov 06, 2020
cobas u 701 microscopy analyzer
LKM
Counter, Urine Particle
224d
Not Cleared
Sep 17, 2020
HemosIL Liquid Anti-Xa
QLU
Anti-factor Xa Activity Test System, Apixaban
450d
Cleared
Aug 19, 2020
HemosIL von Willebrand Factor Antigen
GGP
Test, Qualitative And Quantitative Factor Deficiency
225d
Cleared
Mar 15, 2019
CELL-DYN Emerald 22 AL System
GKZ
Counter, Differential Cell
32d
Cleared
Jan 25, 2019
Sysmex XN-L Automated Hematology Analyzer
GKZ
Counter, Differential Cell
143d
Cleared
Dec 14, 2018
CAPI 3 HEMOGLOBIN(E)
GKA
Abnormal Hemoglobin Quantitation
266d
Cleared
Oct 30, 2018
Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device
JOY
Device, Automated Cell-locating
90d
Cleared
Apr 23, 2018
Sysmex UF-5000 Fully Automated Urine Particle Analyzer
LKM
Counter, Urine Particle
304d
Cleared
Apr 19, 2018
CoaguChek XS Plus System
GJS
Test, Time, Prothrombin
35d
Cleared
Apr 19, 2018
CoaguChek XS Pro System
GJS
Test, Time, Prothrombin
34d
Cleared
Mar 22, 2018
HemosIL Factor XII Deficient Plasma
GJT
Plasma, Coagulation Factor Deficient
27d
Cleared
Feb 15, 2018
Instant-view-PLUS immunochemical Fecal Occult Blood Test
KHE
Reagent, Occult Blood
136d
Cleared
Jan 12, 2018
cobas Factor II and Factor V Test
NPR
Test, Factor Ii G20210a Mutations, Genomic Dna Pcr
109d
Cleared
Dec 25, 2017
CoaguChek Vantus System
GJS
Test, Time, Prothrombin
269d
Cleared
Nov 22, 2017
HemosIL D-Dimer HS 500
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
61d
Cleared
Nov 06, 2017
XW-100 Automated Hematology Analyzer for CLIA Waived Use
GKZ
Counter, Differential Cell
68d
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