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
Feb 06, 2002
SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL
GGC
Control, Plasma, Abnormal
26d
Cleared
Feb 06, 2002
R & D BODY FLUID CONTROL
JPK
Mixture, Hematology Quality Control
14d
Cleared
Feb 01, 2002
BD VACUTAINER SAFETY COAGULATION TUBE
JKA
Tubes, Vials, Systems, Serum Separators, Blood Collection
60d
Cleared
Jan 24, 2002
HEMOCHRON JR. CITRATE APTT CUVETTE
GFO
Activated Partial Thromboplastin
50d
Cleared
Jan 22, 2002
ACCU-BASE HEMOGLOBIN A1C SAMPLE COLLECTION KIT
LCP
Assay, Glycosylated Hemoglobin
96d
Cleared
Jan 22, 2002
R&D RET-LINE KIT
JPK
Mixture, Hematology Quality Control
60d
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
Dec 10, 2001
REFERENCE CHECK, CATALOG NUMBER-RCN-10
GIZ
Plasma, Control, Normal
32d
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
Oct 16, 2001
ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY (RPFA)
JOZ
System, Automated Platelet Aggregation
167d
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 21, 2001
SQA, SPERM QUALITY ANALYZER
POV
Semen Analysis Device
58d
Cleared
Sep 21, 2001
ADVIA 120 HEMATOLOGY SYSTEM, CYANIDE-FREE HIGH DETERMINATION
GKZ
Counter, Differential Cell
23d
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
Sep 14, 2001
ACTICLOT PROTEIN S, MODEL 843L
GGP
Test, Qualitative And Quantitative Factor Deficiency
49d
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