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
Aug 02, 2010
LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV
JPK
Mixture, Hematology Quality Control
455d
Cleared
Aug 02, 2010
STA-HYBRID HEP CALIBRATOR
JIT
Calibrator, Secondary
312d
Cleared
Jul 28, 2010
ADVIA 2120/2120I BODY FLUIDS
GKZ
Counter, Differential Cell
532d
Cleared
Jul 19, 2010
IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10
KHE
Reagent, Occult Blood
194d
Cleared
Jul 01, 2010
BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST
KHE
Reagent, Occult Blood
104d
Cleared
Jun 25, 2010
LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA
GIR
Reagent, Russel Viper Venom
543d
Cleared
Jun 11, 2010
INRATIO/INRATIO2 TEST STRIPS
GJS
Test, Time, Prothrombin
256d
Cleared
May 12, 2010
EASYCELL CELL LOCATOR
JOY
Device, Automated Cell-locating
302d
Cleared
May 04, 2010
SPERMCHECK FERTILITY
POV
Semen Analysis Device
88d
Cleared
Apr 28, 2010
ILLUMINA BEADXPRESS SYSTEM
NSU
Instrumentation For Clinical Multiplex Test Systems
208d
Cleared
Apr 08, 2010
BC-3200 AUTO HEMATOLOGY ANALYZER,M-30D DILUENT, M-30R RINSE, M-30CFL LYSE, M-30E-Z CLEANSER, M-30PROBE CLEANSER, BC-3D C
GKZ
Counter, Differential Cell
160d
Cleared
Apr 07, 2010
COAGUSENSE SELF-TEST PROTHROMBIN TIME/INR MONITORING SYSTEM
GJS
Test, Time, Prothrombin
174d
Cleared
Mar 30, 2010
SYSMEX MODEL XT-4000I
GKZ
Counter, Differential Cell
330d
Cleared
Mar 23, 2010
ROTEM DELTA THROMBOELASTOMETRY SYSTEM
JPA
System, Multipurpose For In Vitro Coagulation Studies
454d
Cleared
Mar 18, 2010
COAGUCHEK XS PRO SYSTEM
GJS
Test, Time, Prothrombin
132d
Cleared
Mar 05, 2010
COAGUCHEK XS PLUS PST SYSTEM
GJS
Test, Time, Prothrombin
162d
Cleared
Feb 22, 2010
CAPILLARYS NEONAT HB (PN 2006)
GKA
Abnormal Hemoglobin Quantitation
297d
Cleared
Feb 05, 2010
HEMOSIL D-DIMER HS 500, CONTROLS
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
367d
Cleared
Jan 29, 2010
R & D SYSTEMS XERET HEMATOLOGY CONTROL
JPK
Mixture, Hematology Quality Control
21d
Cleared
Jan 21, 2010
BD MICROTAINER MAP MICROTUBE FOR AUTOMATED PROCESS, MODEL 363706
JKA
Tubes, Vials, Systems, Serum Separators, Blood Collection
28d
Cleared
Jan 08, 2010
OC-SENSOR DIANA IFOB TEST
OOX
Automated Occult Blood Analyzer
157d
Cleared
Dec 22, 2009
STA LIATEST FREE PS
GGP
Test, Qualitative And Quantitative Factor Deficiency
154d
Cleared
Dec 22, 2009
STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER
JPA
System, Multipurpose For In Vitro Coagulation Studies
76d
Cleared
Dec 18, 2009
STA-R EVOLUTION EXPERT SERIES HEMOSTASIS SYSTEM AUTOMATED MULTI-PARAMETRIC ANALYZER
JPA
System, Multipurpose For In Vitro Coagulation Studies
81d
Cleared
Nov 20, 2009
CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127
JOY
Device, Automated Cell-locating
63d
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