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
Apr 09, 2001
STA -CALIBRATOR HBPM/LMWH KIT
GGN
Plasma, Coagulation Control
63d
Cleared
Apr 03, 2001
ADVIA RETIC PLUS
JPK
Mixture, Hematology Quality Control
46d
Cleared
Mar 23, 2001
SYNOVIALSCOPICS, SYNOVIAL FLUID CONTROL
JPK
Mixture, Hematology Quality Control
23d
Cleared
Mar 22, 2001
THROMBOMAX-HS WITH CALCIUM, MODEL T6540
GGO
Reagent, Thromboplastin And Control
64d
Cleared
Mar 16, 2001
ROCHE DIAGNOSTICS TINA-QUANT D-DIMER ON COBAS INTEGRA
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
198d
Cleared
Mar 16, 2001
CBC-SF
JPK
Mixture, Hematology Quality Control
32d
Cleared
Mar 15, 2001
SIGMA DIAGNOSTICS AUTO D-DIMER, MODEL CRS126-A
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
148d
Cleared
Mar 15, 2001
DIFFMASTER OCTAVIA AUTOMATIC HEMATOLOGY ANALYZER
JOY
Device, Automated Cell-locating
146d
Cleared
Mar 01, 2001
ACCUCLOT CONTROL I, MODEL A4089
GIZ
Plasma, Control, Normal
128d
Cleared
Mar 01, 2001
SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217
GGC
Control, Plasma, Abnormal
128d
Cleared
Feb 23, 2001
EASE-A-CULT
KHE
Reagent, Occult Blood
171d
Cleared
Feb 20, 2001
THROMBOREL S
GJS
Test, Time, Prothrombin
67d
Cleared
Feb 12, 2001
ASSERACHROM HPIA TEST KIT
LCO
Platelet Factor 4 Radioimmunoassay
68d
Cleared
Feb 07, 2001
4C-ES CELL, MODELS 7547187, 7547188, 7547189, 7547190
JPK
Mixture, Hematology Quality Control
30d
Cleared
Feb 07, 2001
5C-ES CELL CONTROL, MODELS 7547191, 7547192
JPK
Mixture, Hematology Quality Control
30d
Cleared
Feb 05, 2001
MINIQUANT D-DIMER, MODEL 1447
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
165d
Cleared
Feb 05, 2001
ADVIA 120 HEMATOLOGY
GKZ
Counter, Differential Cell
59d
Cleared
Jan 22, 2001
INSTACCULT
KHE
Reagent, Occult Blood
124d
Cleared
Jan 16, 2001
CD-CAL PLUS CALIBRATOR
KRX
Calibrator For Cell Indices
21d
Cleared
Jan 12, 2001
!NSURE FECAL OCCULT BLOOD TEST
KHE
Reagent, Occult Blood
155d
Cleared
Jan 12, 2001
CBC-4K HEMATOLOGY CONTROL
JPK
Mixture, Hematology Quality Control
28d
Cleared
Dec 26, 2000
ABX PENTRA 60C+ HEMATOLOGY ANALYZER
GKZ
Counter, Differential Cell
27d
Cleared
Dec 19, 2000
VARIANT II TOTAL GHB
LCP
Assay, Glycosylated Hemoglobin
61d
Cleared
Dec 18, 2000
MODIFICATION TO INTEGRA REAGENT CASSETTE FOR HEMOGLOBIN A1C
LCP
Assay, Glycosylated Hemoglobin
74d
Cleared
Dec 01, 2000
PENTRA 5D
JPK
Mixture, Hematology Quality Control
15d
Looking for a specific hematology device? Search by device name, K-number or manufacturer.
Search all Hematology 510(k) devices