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
2622 Hematology devices
Cleared
Jun 28, 1979
LYOPHILIZED G-HB QUIK COLUMN CONTROL
LCP
Assay, Glycosylated Hemoglobin
10d
Cleared
Jun 22, 1979
TRISEDTA-BORATE ELECTROPHORESIS FILM AGA
GHS
Assay, Carboxyhemoglobin
35d
Cleared
Jun 22, 1979
HEMOGLOBIN AF/SC ELECTROPHORESIS CONTROL
JPK
Mixture, Hematology Quality Control
18d
Cleared
Jun 15, 1979
LO-ION
KSG
Media, Potentiating For In Vitro Diagnostic Use
23d
Cleared
May 31, 1979
COAGULATION ARP
JPK
Mixture, Hematology Quality Control
31d
Cleared
May 24, 1979
TERUMO IMUGARD
GKT
Separator, Automated, Blood Cell, Diagnostic
128d
Cleared
May 23, 1979
IMMU-TEK AUTOMATIC CENTRIFUGE
KSN
Centrifuge, Cell-washing, Automated For Immuno-hematology
34d
Cleared
May 23, 1979
DADE LOW IONIC STRENGTH SOLUITION (LISS)
KSG
Media, Potentiating For In Vitro Diagnostic Use
33d
Cleared
May 16, 1979
TEST CELLS
KSF
Kit, Quality Control For Blood Banking Reagents
97d
Cleared
May 03, 1979
BETA/PAK
JOZ
System, Automated Platelet Aggregation
14d
Cleared
Apr 23, 1979
QUIK-STAIN
IAF
Wright's Stain
31d
Cleared
Apr 23, 1979
QUIK COLUMN METHODOLOGY
LCP
Assay, Glycosylated Hemoglobin
27d
Cleared
Apr 04, 1979
FACTOR V DEFICIENT
GGP
Test, Qualitative And Quantitative Factor Deficiency
34d
Cleared
Apr 04, 1979
HEMOGLOBIN CONTROLS
JPK
Mixture, Hematology Quality Control
30d
Cleared
Apr 03, 1979
LISS REAGENT
KSG
Media, Potentiating For In Vitro Diagnostic Use
21d
Cleared
Apr 03, 1979
HEMATROL S HEMATOLOGY CONTROLS
JPK
Mixture, Hematology Quality Control
19d
Cleared
Mar 21, 1979
COAG-A-MATE 2001
JPA
System, Multipurpose For In Vitro Coagulation Studies
34d
Cleared
Mar 21, 1979
ACTIVATOR
JBP
Activated Whole Blood Clotting Time
28d
Cleared
Mar 12, 1979
PLASMA, STANDARDIZED NORMAL
JPA
System, Multipurpose For In Vitro Coagulation Studies
41d
Cleared
Feb 26, 1979
FLUID, RHEMOX W LYSING
GGK
Products, Red-cell Lysing Products
54d
Cleared
Feb 26, 1979
DETERMINATION OF ANTITHROMBIN III, 885
JBQ
Antithrombin Iii Quantitation
41d
Cleared
Feb 15, 1979
HEPARIN ASSAY
KFF
Assay, Heparin
171d
Cleared
Feb 15, 1979
DILUENT, CELLENT BLOOD
GIF
Diluent, Blood Cell
43d
Cleared
Feb 15, 1979
STAIN, HEMASTAIN RETIC
GJH
Stain, Reticulocyte
41d
Cleared
Feb 08, 1979
ANALYZER, MODEL CC-720
GKL
Counter, Cell, Automated (particle Counter)
36d
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