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
Jan 18, 2002
DADE THROMBOPLASTIN C PLUS
GJS
Test, Time, Prothrombin
119d
Cleared
Jan 10, 2002
ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752
JBP
Activated Whole Blood Clotting Time
118d
Cleared
Dec 26, 2001
SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
63d
Cleared
Dec 13, 2001
IMMUNO-TROL LOW CELLS
JPK
Mixture, Hematology Quality Control
23d
Cleared
Nov 15, 2001
SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
22d
Cleared
Nov 15, 2001
SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
22d
Cleared
Nov 09, 2001
BCS SYSTEM
JPA
System, Multipurpose For In Vitro Coagulation Studies
52d
Cleared
Nov 06, 2001
SICKLE-CHEX
GHM
Test, Sickle Cell
33d
Cleared
Oct 26, 2001
INFINITY HBA KIT, MODELS 537-A, 537-B
LCP
Assay, Glycosylated Hemoglobin
88d
Cleared
Sep 28, 2001
PLATELETWORKS
JOZ
System, Automated Platelet Aggregation
44d
Cleared
Sep 28, 2001
CELL-DYN 3200 SYSTEM WITH ABSOLUTE AND PERCENT RETICULOCYTE
GKZ
Counter, Differential Cell
28d
Cleared
Sep 18, 2001
G7 AUTOMATED HPLC ANALYZER
LCP
Assay, Glycosylated Hemoglobin
131d
Cleared
Sep 18, 2001
LYPHOCHEK COAGULATION CONTROL LEVEL 1, LYPHOCHEK COAGULATION LEVEL 2, LYPHOCHEK COAGULATION LEVEL 3, MODELS 781,782,783
GGN
Plasma, Coagulation Control
34d
Cleared
Sep 18, 2001
HEMOSIL RECOMBI PLASTIN
GJS
Test, Time, Prothrombin
32d
Cleared
Aug 21, 2001
K-ASSAY D-DIMER CONTROLS
GGC
Control, Plasma, Abnormal
22d
Cleared
Aug 09, 2001
BCT SYSTEM
JPA
System, Multipurpose For In Vitro Coagulation Studies
71d
Cleared
Jul 20, 2001
SYSMEX AUTOMATED COAGULATION ANALYZER / MODEL # CA-1500
JPA
System, Multipurpose For In Vitro Coagulation Studies
88d
Cleared
Jul 10, 2001
SYNCHRON SYSTEMS HEMOGLOBIN A1C REAGENT
LCP
Assay, Glycosylated Hemoglobin
119d
Cleared
Jul 09, 2001
COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632
GKZ
Counter, Differential Cell
68d
Cleared
Jul 02, 2001
PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE
GJS
Test, Time, Prothrombin
124d
Cleared
Jun 26, 2001
PARA 5X
JPK
Mixture, Hematology Quality Control
49d
Cleared
Jun 25, 2001
IL TEST PROS
GGP
Test, Qualitative And Quantitative Factor Deficiency
47d
Cleared
Jun 21, 2001
DADE PFA-100 PLATELET FUNCTION ANALYZER MODEL-100, DADE PFA COLLEGEN/EPINEPHRINE TEST CARTRIDE, DADE PFA COLLEAGEN /ADP
JOZ
System, Automated Platelet Aggregation
279d
Cleared
Jun 06, 2001
HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS
KFF
Assay, Heparin
135d
Cleared
Jun 06, 2001
CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAY
GKZ
Counter, Differential Cell
68d
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