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
Jul 17, 1997
CRYO CHECK FACTOR VII DEFICIENT PLASMA
GJT
Plasma, Coagulation Factor Deficient
106d
Cleared
Jul 17, 1997
CRYO CHECK FACTOR VIII DEFICIENT PLASMA
GJT
Plasma, Coagulation Factor Deficient
106d
Cleared
Jul 14, 1997
ORTHO-MUNE OKT 4A (CD4) - MONOCLONAL ANTIBODY (MURINE) FITC CONJUGATE
GKZ
Counter, Differential Cell
837d
Cleared
Jul 14, 1997
FACTOR DEFICIENT PLASMAS - FACTOR XI (11)
GJT
Plasma, Coagulation Factor Deficient
25d
Cleared
Jul 14, 1997
FACTOR DEFICIENT PLASMAS - FACTOR IX (9)
GGP
Test, Qualitative And Quantitative Factor Deficiency
25d
Cleared
Jun 30, 1997
COULTER ACT TRON CELL CONTROL
JPK
Mixture, Hematology Quality Control
69d
Cleared
Jun 26, 1997
STA LIATEST CONTROL [N]+[P] KIT
GGN
Plasma, Coagulation Control
213d
Cleared
Jun 26, 1997
STA-LIATEST D-DI TEST KIT
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
213d
Cleared
Jun 24, 1997
MOUSE ANTI-HUMAN CD45, LEUCOCYTE COMMON ANTIGEN (LCA)/FITC AND CD14, MONOCYTE/RPE
GKZ
Counter, Differential Cell
194d
Cleared
Jun 17, 1997
COAGULATION CONTROL PLASMA(ABNORMAL)LEVEL 0
GGN
Plasma, Coagulation Control
61d
Cleared
Jun 17, 1997
DIASCREEN REAGENT STRIPS
LJX
Test, Urine Leukocyte
19d
Cleared
May 30, 1997
MDX 2000, DIGITAL ANALYZER
JOY
Device, Automated Cell-locating
85d
Cleared
May 29, 1997
TAS PT-NCTEST CONTROLS
GGN
Plasma, Coagulation Control
17d
Cleared
May 23, 1997
STA D-DI CALIBRATOR KIT
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
179d
Cleared
May 21, 1997
FIF TM
KQJ
System, Fibrinogen Determination
120d
Cleared
May 19, 1997
BC THROMBIN REAGENT
GJA
Test, Thrombin Time
88d
Cleared
May 14, 1997
CALTAG CAL-LYSE
GKZ
Counter, Differential Cell
134d
Cleared
May 05, 1997
BEHRING COAGULATION SYSTEM
JPA
System, Multipurpose For In Vitro Coagulation Studies
90d
Cleared
Apr 25, 1997
UNIVERSAL REAGENT FACTOR VIII DEFICIENT PLASMA
GJT
Plasma, Coagulation Factor Deficient
66d
Cleared
Apr 25, 1997
UNIVERSAL REAGENT FACTOR VII DEFICIENT PLASMA
GJT
Plasma, Coagulation Factor Deficient
66d
Cleared
Apr 22, 1997
COAGUCHEK PST SYSTEM
GJS
Test, Time, Prothrombin
295d
Cleared
Apr 22, 1997
HYDRAGEL 15 HB A1C KIT
LCP
Assay, Glycosylated Hemoglobin
209d
Cleared
Apr 21, 1997
HUMAN PROTEIN S RID TEST KIT
GGP
Test, Qualitative And Quantitative Factor Deficiency
742d
Cleared
Apr 16, 1997
N-ASSAY TIA FIBRINOGEN TEST KIT
KQJ
System, Fibrinogen Determination
117d
Cleared
Apr 16, 1997
CBC-4K HEMATOLOGY CONTROL
JPK
Mixture, Hematology Quality Control
78d
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