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
Jul 03, 2013
DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MIC
GGN
Plasma, Coagulation Control
457d
Cleared
May 31, 2013
I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2
GGN
Plasma, Coagulation Control
431d
Cleared
Mar 24, 2013
HEMOSIL READIPLAS TIN
GJS
Test, Time, Prothrombin
212d
Cleared
Mar 22, 2013
UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
GKZ
Counter, Differential Cell
373d
Cleared
Jan 24, 2013
DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET
GHH
Fibrin Split Products
549d
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
Nov 23, 2011
ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120I
GKZ
Counter, Differential Cell
435d
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
Jun 23, 2011
AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5
GGN
Plasma, Coagulation Control
468d
Cleared
Jun 08, 2011
HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)
JOX
Analyzer, Heparin, Automated
27d
Cleared
May 16, 2011
STRATUS CS ACUTE CARE D-DIMER
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
104d
Cleared
Apr 28, 2011
R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROL
JPK
Mixture, Hematology Quality Control
325d
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
Mar 07, 2011
BD FACS SAMPLE PREP ASSISTANT III (SPA III)
GKZ
Counter, Differential Cell
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
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
Looking for a specific hematology device? Search by device name, K-number or manufacturer.
Search all Hematology 510(k) devices