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.
3292
Total
3285
Cleared
161d
Avg (2y)
1976
Since
773 Hematology devices
Cleared
Oct 24, 2002
PT S TEST STRIPS AND CONTROLS FOR THE COAGUCHEK S SYSTEM, MODELS 2032422 AND 3271404
GJS
Test, Time, Prothrombin
224d
Cleared
Oct 03, 2002
VIDAS D-DIMER NEW (DD2) ASSAY MODEL#30 442
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
204d
Cleared
Aug 27, 2002
PROTEIN S AC
GGP
Test, Qualitative And Quantitative Factor Deficiency
43d
Cleared
Aug 27, 2002
COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS
JBQ
Antithrombin Iii Quantitation
25d
Cleared
Aug 12, 2002
MAGELLAN AUTOLOGUS PLATELET SEPARATOR, MAG100, MAGELLAN AUTOLOGOUS PLATELET SEPARATOR DEISPOSABLE KIT, MKT300
JQC
Centrifuges (micro, Ultra, Refrigerated) For Clinical Use
63d
Cleared
Aug 07, 2002
MDA D-DIMER
GHH
Fibrin Split Products
61d
Cleared
Aug 07, 2002
COAMATIC AT-400
JBQ
Antithrombin Iii Quantitation
33d
Cleared
Jul 29, 2002
MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632
GKZ
Counter, Differential Cell
26d
Cleared
Jul 12, 2002
PLATELET CONCENTRATE SEPARATION KIT FOR CELSEP CENTRIFUGE SYSTEM
LXG
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
30d
Cleared
Jun 27, 2002
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000
GKP
Instrument, Coagulation, Automated
93d
Cleared
Jun 11, 2002
COULTER CELLPREP
GKH
Apparatus, Automated Blood Cell Diluting
62d
Cleared
May 23, 2002
ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770
JBP
Activated Whole Blood Clotting Time
63d
Cleared
May 16, 2002
HEMOSIL HIGH ABNORMAL CONTROL ASSAYED
GGN
Plasma, Coagulation Control
48d
Cleared
May 14, 2002
HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED)
GGN
Plasma, Coagulation Control
46d
Cleared
May 14, 2002
HEMOSIL NORMAL CONTROL (ASSAYED)
GGN
Plasma, Coagulation Control
46d
Cleared
Apr 15, 2002
LYPHOCHEK HEMOSTASIS, MODELS 798, 799
GGC
Control, Plasma, Abnormal
28d
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 13, 2001
IMMUNO-TROL LOW CELLS
JPK
Mixture, Hematology Quality Control
23d
Cleared
Nov 09, 2001
BCS SYSTEM
JPA
System, Multipurpose For In Vitro Coagulation Studies
52d
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
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 09, 2001
BCT SYSTEM
JPA
System, Multipurpose For In Vitro Coagulation Studies
71d
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