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
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
VISUCAL-F FROZEN CALIBRATOR PLASMA AND VISUCON-F FROZEN NORMAL AND ABNORMAL CONTROL PLASMA
GGN
Plasma, Coagulation Control
180d
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
Jul 31, 2009
BD MULTITEST 6-COLOR TBNK REAGENT, MODEL 644611
GKZ
Counter, Differential Cell
116d
Cleared
Jul 02, 2009
DESTINY MAX COAGULATION ANALYZER
JPA
System, Multipurpose For In Vitro Coagulation Studies
185d
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 08, 2009
HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHEN ACT. PC-R CONTROL PLASMA AND BIOPHEN
GGW
Test, Time, Partial Thromboplastin
143d
Cleared
May 06, 2009
PATHFAST D-DIMER
GHH
Fibrin Split Products
629d
Cleared
Apr 21, 2009
CHEMPAQ XBC ANALYZER
GKZ
Counter, Differential Cell
109d
Cleared
Apr 15, 2009
TRI T-STAT REAGENT ASSAY (DRIED FORM) MODEL 25107-00
GKZ
Counter, Differential Cell
265d
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
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