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
Jul 31, 2012
VIDAS D-DIMER EXCLUSION II (DEX2)
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
307d
Cleared
Jan 04, 2012
HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL
GGN
Plasma, Coagulation Control
65d
Cleared
Dec 22, 2011
CELL-DYN EMERALD 22 SYSTEM
GKZ
Counter, Differential Cell
315d
Cleared
Aug 24, 2011
HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM
GIR
Reagent, Russel Viper Venom
231d
Cleared
Jul 08, 2011
HEMOSIL FACTOR VIII DEFICIENT PLASMA
GJT
Plasma, Coagulation Factor Deficient
163d
Cleared
Apr 05, 2011
HEMOSIL LA POSITIVE CONTROL
GGC
Control, Plasma, Abnormal
210d
Cleared
Mar 17, 2011
HEMOSIL PROTEIN S ACTIVITY ASSAY
GGP
Test, Qualitative And Quantitative Factor Deficiency
227d
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
Nov 18, 2010
COULTER 4C-EX 300 CELL CONTROL
JPK
Mixture, Hematology Quality Control
260d
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
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
Jun 02, 2009
HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS
KFF
Assay, Heparin
125d
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
Cleared
Feb 03, 2009
COULTER BODY FLUID CONTROL
JPK
Mixture, Hematology Quality Control
187d
Cleared
Jan 21, 2009
COULTER 6C CELL CONTROL, MODELS 628027 & A59925
JPK
Mixture, Hematology Quality Control
208d
Cleared
Jan 16, 2009
COULTER LIN-X LINEARITY CONTROL
JPK
Mixture, Hematology Quality Control
219d
Cleared
Dec 19, 2008
UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
GKZ
Counter, Differential Cell
165d
Cleared
Dec 19, 2008
HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED
GGN
Plasma, Coagulation Control
81d
Cleared
Aug 14, 2008
FLOWCARE TLG REAGENT
GKZ
Counter, Differential Cell
73d
Cleared
Jun 25, 2008
HEMOCCULT ICT
KHE
Reagent, Occult Blood
93d
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