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
Sep 07, 2001
PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560
GGN
Plasma, Coagulation Control
178d
Cleared
Aug 21, 2001
K-ASSAY D-DIMER CONTROLS
GGC
Control, Plasma, Abnormal
22d
Cleared
Aug 15, 2001
FERTILMARQ HOME DIAGNOSTIC SCREENING TEST KIT FOR MALE INFERTILITY
POV
Semen Analysis Device
77d
Cleared
Aug 09, 2001
BCT SYSTEM
JPA
System, Multipurpose For In Vitro Coagulation Studies
71d
Cleared
Jul 26, 2001
MODIFICATION TO THERMAL ANGEL
BSB
Warmer, Blood, Non-electromagnetic Radiation
28d
Cleared
Jul 20, 2001
SYSMEX AUTOMATED COAGULATION ANALYZER / MODEL # CA-1500
JPA
System, Multipurpose For In Vitro Coagulation Studies
88d
Cleared
Jul 10, 2001
SYNCHRON SYSTEMS HEMOGLOBIN A1C REAGENT
LCP
Assay, Glycosylated Hemoglobin
119d
Cleared
Jul 09, 2001
COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632
GKZ
Counter, Differential Cell
68d
Cleared
Jul 02, 2001
PROTIME MICROCOAGULATION SYSTEM / PROTIME 3 CUVETTE
GJS
Test, Time, Prothrombin
124d
Cleared
Jun 26, 2001
PARA 5X
JPK
Mixture, Hematology Quality Control
49d
Cleared
Jun 25, 2001
IL TEST PROS
GGP
Test, Qualitative And Quantitative Factor Deficiency
47d
Cleared
Jun 21, 2001
DADE PFA-100 PLATELET FUNCTION ANALYZER MODEL-100, DADE PFA COLLEGEN/EPINEPHRINE TEST CARTRIDE, DADE PFA COLLEAGEN /ADP
JOZ
System, Automated Platelet Aggregation
279d
Cleared
Jun 21, 2001
HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL)
JCM
Control, Hemoglobin, Abnormal
45d
Cleared
Jun 07, 2001
ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN
KFF
Assay, Heparin
129d
Cleared
Jun 06, 2001
HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS
KFF
Assay, Heparin
135d
Cleared
Jun 06, 2001
CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAY
GKZ
Counter, Differential Cell
68d
Cleared
Jun 06, 2001
STA-LIATEST FREE PROTEIN S TEST KIT
GGP
Test, Qualitative And Quantitative Factor Deficiency
68d
Cleared
May 29, 2001
TINA-QUANT D-DIMER TEST SYSTEM
GHH
Fibrin Split Products
46d
Cleared
May 18, 2001
K-ASSAY D-DIMER WITH CALIBRATOR SET AND CALIBRATOR DILUENT
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
239d
Cleared
May 15, 2001
RUBICON PROTHROMBIN TIME MONITORING SYSTEM
GJS
Test, Time, Prothrombin
347d
Cleared
May 11, 2001
R & D 4K RETIC
JPK
Mixture, Hematology Quality Control
80d
Cleared
May 01, 2001
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
JPA
System, Multipurpose For In Vitro Coagulation Studies
70d
Cleared
Apr 13, 2001
IL TEST FREE PROTEIN S
GGP
Test, Qualitative And Quantitative Factor Deficiency
64d
Cleared
Apr 13, 2001
COULTER HMX ANALYZER, MODEL 6605523, COULTER HMX WITH AUTOLOADER, MODEL 6605526
GKZ
Counter, Differential Cell
30d
Cleared
Apr 09, 2001
STA-QUALITY HBPM/LMWH KIT
GGN
Plasma, Coagulation Control
66d
Looking for a specific hematology device? Search by device name, K-number or manufacturer.
Search all Hematology 510(k) devices