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
1853 Hematology devices
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 02, 2010
LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV
JPK
Mixture, Hematology Quality Control
455d
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 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 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
Oct 29, 2009
INNOVANCE D-DIMER, MODEL OPBP09
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
121d
Cleared
Oct 28, 2009
R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROL
JPK
Mixture, Hematology Quality Control
168d
Cleared
Oct 09, 2009
HEMOSIL INR VALIDATE, HEMOSIL ISI CALIBRATE, ISIWEB (SOFTWARE)
GGN
Plasma, Coagulation Control
221d
Cleared
Sep 22, 2009
ACL TOP 700 LAS
GKP
Instrument, Coagulation, Automated
83d
Cleared
Sep 18, 2009
THERMO SCIENTIFIC CYTO-CAL COUNT TUBES
GKZ
Counter, Differential Cell
177d
Cleared
Jun 10, 2009
STANBIO LABORATORY HEMOPOINT H2 DM HEMOGLOBIN MEASUREMENT SYSTEM
GKR
System, Hemoglobin, Automated
147d
Cleared
Jun 02, 2009
HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS
KFF
Assay, Heparin
125d
Cleared
May 28, 2009
INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5
JBQ
Antithrombin Iii Quantitation
339d
Cleared
Mar 13, 2009
ACL ACUSTAR, HEMOSIL ACUSTAR D-DIMER, HEMOSIL ACUSTAR D-DIMER CONTROLS
JPA
System, Multipurpose For In Vitro Coagulation Studies
107d
Cleared
Feb 04, 2009
CELL-DYN EMERALD SYSTEM
GKZ
Counter, Differential Cell
251d
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