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.
3294
Total
3287
Cleared
164d
Avg (2y)
1976
Since
2615 Hematology devices
Cleared
Dec 21, 2010
COULTER LIN-X LINEARITY CONTROL, MODEL A81196
JPK
Mixture, Hematology Quality Control
274d
Cleared
Dec 20, 2010
PT-MULTI-CALIBRATOR, MODEL OPAT07
GGN
Plasma, Coagulation Control
369d
Cleared
Dec 15, 2010
SPECIALTY ASSAYED CONTROL-2
GGC
Control, Plasma, Abnormal
336d
Cleared
Dec 06, 2010
SMARTPREP2 BMAC SYSTEM, SMARTPREP PLATELET CONCENTRATION SYSTEM
JQC
Centrifuges (micro, Ultra, Refrigerated) For Clinical Use
21d
Cleared
Dec 03, 2010
CLOTRAC HEPARINASE TEST CARTIDGE (HTC) COAGULATION CONTROL
GGN
Plasma, Coagulation Control
23d
Cleared
Dec 01, 2010
HEPARIN ASSAY CONTROLS
GGN
Plasma, Coagulation Control
21d
Cleared
Nov 29, 2010
INNOVANCE D-DIMER, MODEL OPBP09
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
370d
Cleared
Nov 18, 2010
COULTER 4C-EX 300 CELL CONTROL
JPK
Mixture, Hematology Quality Control
260d
Cleared
Nov 04, 2010
HEPARIN DOSE RESPONSE CARTRIDGE
JOX
Analyzer, Heparin, Automated
31d
Cleared
Oct 13, 2010
HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX
JOX
Analyzer, Heparin, Automated
160d
Cleared
Oct 01, 2010
ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800
OSL
Control, Fecal Occult Blood
92d
Cleared
Aug 23, 2010
CELL-CHEX
GLQ
Mixture, Control, White-cell And Red-cell Indices
103d
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 01, 2010
BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST
KHE
Reagent, Occult Blood
104d
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 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
Mar 30, 2010
SYSMEX MODEL XT-4000I
GKZ
Counter, Differential Cell
330d
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
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