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.
3297
Total
3290
Cleared
164d
Avg (2y)
1976
Since
3297 Hematology devices
Cleared
Jul 17, 1979
HEMATRAK MODEL 480
GKZ
Counter, Differential Cell
81d
Cleared
Jul 17, 1979
CONTEXT FILTER
GKZ
Counter, Differential Cell
33d
Cleared
Jul 17, 1979
SICKLE-CELL F TEST
KQI
Assay, Fetal Hemoglobin
29d
Cleared
Jun 28, 1979
CITRATE AGAR GEL AND BUFFER SET
JBD
System, Analysis, Electrophoretic Hemoglobin
41d
Cleared
Jun 28, 1979
PROTHROMBIN FREE BEEF PLASMA (PFB)
GJS
Test, Time, Prothrombin
29d
Cleared
Jun 28, 1979
LEECO GLYCO-HEMOGLOBIN DIAGNOSTIC KIT
LCP
Assay, Glycosylated Hemoglobin
15d
Cleared
Jun 28, 1979
LOW IONIC STRENGTH SOLUTION (LISS)
KSG
Media, Potentiating For In Vitro Diagnostic Use
13d
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
Jun 12, 1979
ESTERASE-CHLOROESTERASE, STAINING KIT
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 04, 1979
ELDONCARD
KSZ
System, Test, Automated Blood Grouping And Antibody
80d
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
CPK ISOENZYME SUBSTRATE
JHY
Colorimetric Method, Cpk Or Isoenzymes
50d
Cleared
Apr 04, 1979
HCP-7
JPK
Mixture, Hematology Quality Control
37d
Cleared
Apr 04, 1979
FACTOR V DEFICIENT
GGP
Test, Qualitative And Quantitative Factor Deficiency
34d
Cleared
Apr 04, 1979
ISOTONIC DILUENT
GIF
Diluent, Blood Cell
28d
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