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.
3294
Total
3287
Cleared
164d
Avg (2y)
1976
Since
2615 Hematology devices
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
Dec 22, 2009
STA LIATEST FREE PS
GGP
Test, Qualitative And Quantitative Factor Deficiency
154d
Cleared
Dec 22, 2009
STA COMPACT AUTOMATED MULTI-PARAMETRIC ANALYZER
JPA
System, Multipurpose For In Vitro Coagulation Studies
76d
Cleared
Nov 13, 2009
STA - FREE PS CALIBRATOR
JIX
Calibrator, Multi-analyte Mixture
122d
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
May 06, 2009
PATHFAST D-DIMER
GHH
Fibrin Split Products
629d
Cleared
Mar 27, 2009
UA-CELLULAR FOR IQ
JPK
Mixture, Hematology Quality Control
59d
Cleared
Mar 26, 2009
MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227
GKA
Abnormal Hemoglobin Quantitation
231d
Cleared
Mar 26, 2009
THE BELMONT BUDDY LITE FLUID WARMER
BSB
Warmer, Blood, Non-electromagnetic Radiation
28d
Cleared
Mar 18, 2009
STAK-CHEX PLUS RETICS
GLQ
Mixture, Control, White-cell And Red-cell Indices
56d
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 11, 2009
CD4 COUNT
GGL
Control, White-cell
42d
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
Feb 03, 2009
X-CAL
KRX
Calibrator For Cell Indices
96d
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
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