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
Aug 04, 2020
HemoCue Hb 301 System
GKR
System, Hemoglobin, Automated
90d
Cleared
Jul 17, 2020
Cryocheck Chromogenic Factor VIII
GGP
Test, Qualitative And Quantitative Factor Deficiency
240d
Cleared
Jun 18, 2020
PF4 IgG assay
LCO
Platelet Factor 4 Radioimmunoassay
31d
Cleared
Jun 12, 2020
Hemo Control (optional Add Pack Hemo Control DM)
GKR
System, Hemoglobin, Automated
67d
Cleared
Apr 16, 2020
Unicel DxH 800 Coulter Cellular Analysis System
GKZ
Counter, Differential Cell
156d
Cleared
Feb 28, 2020
i-STAT CHEM8+ cartridge with the i-STAT 1 System
JPI
Device, Hematocrit Measuring
427d
Cleared
Feb 14, 2020
T-TAS 01 Total Thrombus-formation Analysis System Instrument, PL Chip for T-TAS 01, PL Chip Reservoir Set for T-TAS 01, BAPA tube for T-TAS 01
JOZ
System, Automated Platelet Aggregation
268d
Cleared
Jan 02, 2020
OC-Auto SENSOR io iFOB Test
OOX
Automated Occult Blood Analyzer
247d
Cleared
Nov 22, 2019
Hemochron Signature Elite
JPA
System, Multipurpose For In Vitro Coagulation Studies
22d
Cleared
Nov 15, 2019
HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo High
GGM
Control, Hemoglobin
43d
Cleared
Nov 01, 2019
Sight OLO
GKZ
Counter, Differential Cell
210d
Cleared
Aug 21, 2019
QNext and DG-PT
JPA
System, Multipurpose For In Vitro Coagulation Studies
258d
Cleared
Aug 02, 2019
ADVIA Centaur Erythropoietin (EPO) assay
GGT
Assay, Erythropoietin
269d
Cleared
Jun 27, 2019
SwimCount Sperm Quality Test
POV
Semen Analysis Device
183d
Cleared
May 30, 2019
PureBMC SupraPhysiologic Concentrating System 30 mL System, PureBMC SupraPhysiologic Concentrating System 60 mL System, PureBMC SupraPhysiologic Concentrating System 120 mL System
JQC
Centrifuges (micro, Ultra, Refrigerated) For Clinical Use
192d
Cleared
May 09, 2019
TEG 6s Hemostasis System, TEG 6s Citrated: K, RT, FF Assay Cartridge
JPA
System, Multipurpose For In Vitro Coagulation Studies
175d
Cleared
Mar 29, 2019
AggreGuide A-100 ADP
JOZ
System, Automated Platelet Aggregation
269d
Cleared
Mar 15, 2019
CELL-DYN Emerald 22 AL System
GKZ
Counter, Differential Cell
32d
Cleared
Mar 12, 2019
CRYOcheck FVIII Inhibitor Kit
GGP
Test, Qualitative And Quantitative Factor Deficiency
90d
Not Cleared
Mar 12, 2019
Quantra Hemostasis Analyzer, QPlus Cartridge
QFR
Coagulation System For The Measurement Of Whole Blood Viscoelastic Properties
344d
Cleared
Mar 01, 2019
DxH 520 Hematology Instrument
GKZ
Counter, Differential Cell
270d
Cleared
Feb 21, 2019
Coag-Sense Prothrombin Time (PT) / INR Monitoring Device
GJS
Test, Time, Prothrombin
92d
Cleared
Feb 01, 2019
HemoCue Hb 801 System
GKR
System, Hemoglobin, Automated
214d
Cleared
Feb 01, 2019
HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - High
GGM
Control, Hemoglobin
126d
Cleared
Jan 25, 2019
microINR System
GJS
Test, Time, Prothrombin
305d
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