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
Feb 03, 2009
MEDONIC M SERIES
GKZ
Counter, Differential Cell
76d
Cleared
Jan 26, 2009
BERICHROM HEPARIN LMW CALIBRATOR, BERICHROM HEPARIN LMW CONTROL 1, AND BERICHROM HEPARIN LMW CONTROL 2
JPA
System, Multipurpose For In Vitro Coagulation Studies
91d
Cleared
Jan 26, 2009
BERICHROM HEPARIN UF CALIBRATOR, BERICHROM HEPARIN UF CONTROL 1, AND BERICHROM HEPARIN UF CONTROL 2
JPA
System, Multipurpose For In Vitro Coagulation Studies
90d
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
Dec 17, 2008
THROMBO TEK PSE, MODEL 90-480
GGP
Test, Qualitative And Quantitative Factor Deficiency
98d
Cleared
Dec 12, 2008
STA SATELLITE AUTOMATED MULTI-PARAMETER ANALYZER
JPA
System, Multipurpose For In Vitro Coagulation Studies
126d
Cleared
Dec 05, 2008
CELLAVISION DM96 WITH THE BODY FLUID APPLICATION
JOY
Device, Automated Cell-locating
277d
Cleared
Nov 20, 2008
FACTOR VIII ANTIBODY SCREEN
GGP
Test, Qualitative And Quantitative Factor Deficiency
107d
Cleared
Oct 24, 2008
INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
127d
Cleared
Oct 23, 2008
BINAXNOW G6PD TEST
JBF
Glucose-6-phosphate Dehydrogenase (erythrocytic), Screening
295d
Cleared
Oct 10, 2008
SYSMEX XT-SERIES IG PARAMETER,SYSMEX XT-SERIES RET-HE PARAMETER
GKZ
Counter, Differential Cell
100d
Cleared
Oct 10, 2008
STA-R EVOLUTION AUTOMATED MULTI-PARAMETRIC ANALYZER
JPA
System, Multipurpose For In Vitro Coagulation Studies
25d
Cleared
Aug 29, 2008
SYSMEX MODEL XS-1000IC AUTOMATED HEMATOLOGY ANALYZER
GKZ
Counter, Differential Cell
81d
Cleared
Aug 14, 2008
BD FACSCOUNT CD4 REAGENTS WITH MODEL 339010
GKZ
Counter, Differential Cell
106d
Cleared
Aug 14, 2008
FLOWCARE TLG REAGENT
GKZ
Counter, Differential Cell
73d
Cleared
Jul 31, 2008
HEMOSIL D-DIMER
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
276d
Cleared
Jul 31, 2008
CYTO-CHEX BCT
GIM
Tubes, Vacuum Sample, With Anticoagulant
154d
Cleared
Jul 18, 2008
STANBIO LABORATORY HEMOPOINT H2 HEMOGLOBIN MEASUREMENT SYSTEM
GKR
System, Hemoglobin, Automated
30d
Cleared
Jul 10, 2008
AXP PLATFORM MARROW XPRESS SYSTEM MODEL 8-5137, 8-5138, 8-5139, 8-5140 (PRIMARY)
JQC
Centrifuges (micro, Ultra, Refrigerated) For Clinical Use
57d
Cleared
Jun 25, 2008
HEMOCCULT ICT
KHE
Reagent, Occult Blood
93d
Cleared
May 04, 2008
ACL TOP (WITH SYSTEM SOFTWARE V3.0.0)
GKP
Instrument, Coagulation, Automated
153d
Cleared
May 02, 2008
VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTEM AND VARIANT NBS WORKSTATION WITH
GKA
Abnormal Hemoglobin Quantitation
30d
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