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
Jun 27, 2003
K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
114d
Cleared
Jun 06, 2003
CALIBRATION PLASMA LMW HEPARIN
JIS
Calibrator, Primary
71d
Cleared
Jun 06, 2003
CONTROL PLASMA LMW HEPARIN
GGN
Plasma, Coagulation Control
71d
Cleared
May 22, 2003
COAGUCHEK PT.S TEST FOR PROTHROMBIN TIME SELF-TESTING
GJS
Test, Time, Prothrombin
66d
Cleared
May 21, 2003
TETRACXP SYSTEM (SOFTWARE AND SYSTEM GUIDE)
GKZ
Counter, Differential Cell
68d
Cleared
May 19, 2003
HEMOSIL FACTOR X DEFICIENT PLASMA
GJT
Plasma, Coagulation Factor Deficient
41d
Cleared
May 12, 2003
CELL-DYN 1800 SYSTEM
GKZ
Counter, Differential Cell
82d
Cleared
Apr 28, 2003
CHROMOCHECK ANTITHROMBIN 25
JBQ
Antithrombin Iii Quantitation
146d
Cleared
Apr 21, 2003
COULTER LH 750 BODY FLUIDS APPLICATION
GKZ
Counter, Differential Cell
55d
Cleared
Apr 17, 2003
COULTER ACT 5DIFF AUTOLOADER (AL)
GKZ
Counter, Differential Cell
79d
Cleared
Apr 11, 2003
AUTOLOGEL PROCESS CENTRIFUGE, MODEL B4360 (100-103, 100-129)
JQC
Centrifuges (micro, Ultra, Refrigerated) For Clinical Use
70d
Cleared
Apr 11, 2003
GPS PLATELET SEPARATION KIT WITH ANTICOAGULANT ACD-A
JQC
Centrifuges (micro, Ultra, Refrigerated) For Clinical Use
49d
Cleared
Apr 08, 2003
MICROS 60
GKZ
Counter, Differential Cell
26d
Cleared
Apr 02, 2003
COLONCARE
KHE
Reagent, Occult Blood
71d
Cleared
Apr 02, 2003
HEMOCHRON RESPONSE/SYSTEM
JPA
System, Multipurpose For In Vitro Coagulation Studies
19d
Cleared
Apr 01, 2003
MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEM
GHH
Fibrin Split Products
22d
Cleared
Mar 19, 2003
CHROMOCHECK PROTEIN C 25
GGP
Test, Qualitative And Quantitative Factor Deficiency
106d
Cleared
Mar 19, 2003
HEMOSIL FACTOR XI DEFICIENT PLASMA
GJT
Plasma, Coagulation Factor Deficient
50d
Cleared
Mar 04, 2003
CYTO-STAT TETRACHROME CD45-FIT/CD4-PE/CD3-PC5 MONOCLONAL ANTIBODY REAGENT, CYTO-STAT TETRACHROM CD45-FITC/CD56-PE/CD19-A
GKZ
Counter, Differential Cell
25d
Cleared
Feb 24, 2003
LIQUICHEK D-DIMER CONTROL, MODEL 356, 357
GGN
Plasma, Coagulation Control
38d
Cleared
Feb 14, 2003
PLATELETWORKS, MODELS PW-A, PW-C
JOZ
System, Automated Platelet Aggregation
98d
Cleared
Feb 12, 2003
HEMOSIL FACTOR VII DEFICIENT PLASMA
GJT
Plasma, Coagulation Factor Deficient
63d
Cleared
Jan 31, 2003
ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM
GKR
System, Hemoglobin, Automated
100d
Cleared
Jan 31, 2003
MODIFICATION TO PENTRA 60 AND PENTRA 60C+
GKZ
Counter, Differential Cell
16d
Cleared
Jan 16, 2003
STRATUS CS D-DIMER (DDMR) METHOD (TESTPAK & DILPAK), MODELS CDDMR & CDDMR-D
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
132d
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