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
2614 Hematology devices
Cleared
Nov 01, 2017
ABX MICROS ES 60 OT and ABX MICROS ES 60 CT
GKZ
Counter, Differential Cell
271d
Cleared
Oct 31, 2017
Sysmex CS-5100
JPA
System, Multipurpose For In Vitro Coagulation Studies
90d
Cleared
Oct 05, 2017
InSure ONE
KHE
Reagent, Occult Blood
223d
Cleared
Sep 13, 2017
AnemoCheck
KHG
Whole Blood Hemoglobin Determination
301d
Cleared
Sep 13, 2017
Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview Software
GKA
Abnormal Hemoglobin Quantitation
100d
Cleared
Sep 08, 2017
hemochroma PLUS System
GKR
System, Hemoglobin, Automated
270d
Cleared
Sep 08, 2017
HemosIL AcuStar HIT-IgG(PF4-H), HemosIL AcuStar HIT Controls
LCO
Platelet Factor 4 Radioimmunoassay
170d
Cleared
Aug 22, 2017
INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF and Heparin LMW Controls
KFF
Assay, Heparin
344d
Cleared
Aug 22, 2017
i-STAT Hematocrit test with i-STAT Alinity System
JPI
Device, Hematocrit Measuring
266d
Cleared
Aug 11, 2017
ADVIA 2120i, ADVIA 2120
GKZ
Counter, Differential Cell
289d
Cleared
Aug 08, 2017
AFIAS iFOB with AFIAS-50
OOX
Automated Occult Blood Analyzer
264d
Cleared
Aug 01, 2017
Advanced RBC Application
JOY
Device, Automated Cell-locating
89d
Cleared
Jun 21, 2017
VALIDATE D-Dimer Calibration Verification / Linearity Test Kit
GGN
Plasma, Coagulation Control
90d
Cleared
Jun 14, 2017
hema-screen SPECIFIC Gold
KHE
Reagent, Occult Blood
23d
Cleared
May 14, 2017
Wondfo One Step Fecal Occult Blood (FOB) Test
KHE
Reagent, Occult Blood
265d
Cleared
Apr 19, 2017
TEG 6s Hemostasis System
JPA
System, Multipurpose For In Vitro Coagulation Studies
421d
Not Cleared
Apr 06, 2017
23andMe Personal Genome Service (PGS) Genetic Health Risk Test for Hereditary Thrombophilia
PTA
Genetic Variant Detection And Health Risk Assessment System
282d
Cleared
Apr 05, 2017
AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument
JOZ
System, Automated Platelet Aggregation
135d
Cleared
Mar 16, 2017
VALIDATE Heparin Calibration Verification/Linearity Test Kit
GGN
Plasma, Coagulation Control
93d
Cleared
Mar 03, 2017
ACL AcuStar
JPA
System, Multipurpose For In Vitro Coagulation Studies
30d
Cleared
Feb 23, 2017
George King Coumadin Plasma
GGN
Plasma, Coagulation Control
288d
Cleared
Jan 17, 2017
hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test
KHE
Reagent, Occult Blood
29d
Cleared
Jan 05, 2017
VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit
GGN
Plasma, Coagulation Control
99d
Cleared
Dec 26, 2016
Sysmex CS-2100i
JPA
System, Multipurpose For In Vitro Coagulation Studies
90d
Cleared
Dec 22, 2016
Sysmex XN-L Automated Hematology Analyzer
GKZ
Counter, Differential Cell
300d
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