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.
3293
Total
3286
Cleared
158d
Avg (2y)
1976
Since
1855 Hematology devices
Cleared
Sep 17, 1999
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000
GKP
Instrument, Coagulation, Automated
67d
Cleared
Sep 09, 1999
COBE BRAT 2 AUTOLOGOUS BLOOD SALVAGE SYSTEM WITH THE CRIT-LINE HEMATOCRIT SAMPLING SYSTEM OPTION
CAC
Apparatus, Autotransfusion
87d
Cleared
Jul 28, 1999
DADE BEHRING BFTII
JPA
System, Multipurpose For In Vitro Coagulation Studies
222d
Cleared
Jul 12, 1999
IMMULITE EPO, MODEL #'S LKEPZ & LKEP1
GGT
Assay, Erythropoietin
301d
Cleared
Jul 09, 1999
CELL-DYN 3500 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION (IRF), CELL-DYN 3700 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION
GKZ
Counter, Differential Cell
60d
Cleared
Jun 23, 1999
CELL-DYN 1200 SYSTEM
GKZ
Counter, Differential Cell
79d
Cleared
Jun 21, 1999
DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE-CY5, CLONE UCHT1 & DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE, CLONE UCHT1
GKZ
Counter, Differential Cell
60d
Cleared
Jun 21, 1999
MOUSE IGG1 NEGATIVE CONTROLS
GKZ
Counter, Differential Cell
56d
Cleared
Jun 17, 1999
SEDRITE PLUS ERYTHROCYTE SEDIMENTATION RATE
JPK
Mixture, Hematology Quality Control
15d
Cleared
Jun 10, 1999
VARIANT II B-THALASSEMIA
JPD
Hemoglobin A2 Quantitation
69d
Cleared
Jun 01, 1999
COAG-A-MATE MAX
GKP
Instrument, Coagulation, Automated
61d
Cleared
May 11, 1999
COULTER Z2 ANALYZER
GKL
Counter, Cell, Automated (particle Counter)
41d
Cleared
May 03, 1999
HEMOCHRON RESPONSE
KQG
Instrument, Coagulation
213d
Cleared
Apr 26, 1999
RETICONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS
GKZ
Counter, Differential Cell
83d
Cleared
Apr 21, 1999
LYPOCHEK COAGULATION CONTROL, MODEL NOS. 787, 788, 789
GGN
Plasma, Coagulation Control
37d
Cleared
Apr 13, 1999
TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS WITH CYTO-STAT TETRACHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 MONOCLA
GKZ
Counter, Differential Cell
84d
Cleared
Apr 13, 1999
HEMOCHRON ELECTRONIC SYSTEM VERIFICATION TUBE
JPA
System, Multipurpose For In Vitro Coagulation Studies
60d
Cleared
Apr 08, 1999
IL TEST LAC SCREEN (CLAIMS ADDED TO ACL FUTURA), IL TEST LAC CONFIRM (CLAIMS ADDAD TO ACL FUTURA)
GIR
Reagent, Russel Viper Venom
66d
Cleared
Apr 01, 1999
COULTER AC T DIFF 2 ANALYZER
GKZ
Counter, Differential Cell
55d
Cleared
Mar 23, 1999
ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAY
GGT
Assay, Erythropoietin
391d
Cleared
Mar 16, 1999
IMMUNO-TROL CONTROL CELLS
JPK
Mixture, Hematology Quality Control
112d
Cleared
Feb 17, 1999
CBC-5D HEMATOLOGY CONTROL
JPK
Mixture, Hematology Quality Control
170d
Cleared
Dec 17, 1998
SPIFE ALKALINE HEMOGLOBIN
JBD
System, Analysis, Electrophoretic Hemoglobin
157d
Cleared
Dec 17, 1998
VARIANT II HEMOGLOBIN A1C PROGRAM
LCP
Assay, Glycosylated Hemoglobin
17d
Cleared
Dec 10, 1998
QBC CENTRIFUGAL HEMATOLOGY CONTROL
JPK
Mixture, Hematology Quality Control
23d
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