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.
3293
Total
3286
Cleared
158d
Avg (2y)
1976
Since
1855 Hematology devices
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 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
GPS PLATELET SEPARATION KIT WITH ANTICOAGULANT ACD-A
JQC
Centrifuges (micro, Ultra, Refrigerated) For Clinical Use
49d
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
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 16, 2003
STRATUS CS D-DIMER (DDMR) METHOD (TESTPAK & DILPAK), MODELS CDDMR & CDDMR-D
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
132d
Cleared
Jan 16, 2003
MODIFICATION TO STANDARD HUMAN PLASMA
JPA
System, Multipurpose For In Vitro Coagulation Studies
118d
Cleared
Jan 14, 2003
HEMOSIL FACTOR V DEFICIENT PLASMA
GJT
Plasma, Coagulation Factor Deficient
57d
Cleared
Dec 30, 2002
SICKLE-CHEX SOLUBILITY KIT
GHM
Test, Sickle Cell
61d
Cleared
Nov 27, 2002
STRATUS CS D-DIMER CALPAK CALIBRATOR, MODEL CDDMR-C
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
82d
Cleared
Nov 01, 2002
CONTROL PLASMA N
GIZ
Plasma, Control, Normal
29d
Cleared
Nov 01, 2002
CONTROL PLASMA P
GGC
Control, Plasma, Abnormal
29d
Cleared
Oct 25, 2002
PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM, MODEL# 2032422
GJS
Test, Time, Prothrombin
193d
Cleared
Oct 24, 2002
PT S TEST STRIPS AND CONTROLS FOR THE COAGUCHEK S SYSTEM, MODELS 2032422 AND 3271404
GJS
Test, Time, Prothrombin
224d
Cleared
Oct 03, 2002
VIDAS D-DIMER NEW (DD2) ASSAY MODEL#30 442
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
204d
Cleared
Sep 30, 2002
HARMONY INR MONITORING SYSTEM
GJS
Test, Time, Prothrombin
26d
Cleared
Aug 30, 2002
AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED
JPA
System, Multipurpose For In Vitro Coagulation Studies
141d
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