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.
3294
Total
3287
Cleared
164d
Avg (2y)
1976
Since
2615 Hematology devices
Cleared
Nov 20, 2007
SYSMEX XE-5000
GKZ
Counter, Differential Cell
127d
Cleared
Nov 20, 2007
HC WBC HEMATOLOGY CONTROL, MODEL: WBC00S
JPK
Mixture, Hematology Quality Control
97d
Cleared
Oct 26, 2007
INRATIO 2 PT MONITORING SYSTEM
GJS
Test, Time, Prothrombin
30d
Cleared
Oct 25, 2007
HEMOCUE WBC SYSTEM
GKL
Counter, Cell, Automated (particle Counter)
129d
Cleared
Oct 25, 2007
GENERAL SEMEN ANALYSIS KIT
POV
Semen Analysis Device
121d
Cleared
Oct 11, 2007
VERIGENE SYSTEM, F2 NUCLEIC ACID TEST, F5 NUCLEIC ACID TEST, AND MTHFR NUCLEIC ACID TEST
NSU
Instrumentation For Clinical Multiplex Test Systems
223d
Cleared
Oct 11, 2007
MARROWSTIM CONCENTRATION KIT AND MARROWSTIM MINI CONCENTRATION KIT
JQC
Centrifuges (micro, Ultra, Refrigerated) For Clinical Use
90d
Cleared
Oct 04, 2007
SCANVIEW, MODEL SC-300
JOY
Device, Automated Cell-locating
136d
Cleared
Oct 04, 2007
CYTOMICS FC 500 MPL FLOW CYTOMETER, MODEL # 626554
GKZ
Counter, Differential Cell
107d
Cleared
Sep 19, 2007
FIBRINOGEN CALIBRATOR KIT
GFX
Fibrinogen Standard
33d
Cleared
Sep 17, 2007
HEMOSIL D-DIMER HS
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
167d
Cleared
Sep 07, 2007
ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A
LCO
Platelet Factor 4 Radioimmunoassay
126d
Cleared
Aug 20, 2007
CBC-5D PLUS RETICS HEMATOLOGY CONTROL, MODELS: 5DR03, 5DR04
JPK
Mixture, Hematology Quality Control
20d
Cleared
Aug 15, 2007
SPECTROLYSE PAI-1, MODEL 101201
GGP
Test, Qualitative And Quantitative Factor Deficiency
285d
Cleared
Aug 15, 2007
HEMOSIL RECOMBIPLASTIN 2G
GJS
Test, Time, Prothrombin
224d
Cleared
Jul 10, 2007
MINICOLLECT CAPILLARY BLOOD COLLECTION TUBES
JKA
Tubes, Vials, Systems, Serum Separators, Blood Collection
245d
Cleared
Jun 26, 2007
I-STAT ACTIVATED CLOTTING TIME (ACT) CONTROL SET LEVEL 1 AND LEVEL 2, MODELS 07G82-01, 07G82-02
GGN
Plasma, Coagulation Control
47d
Cleared
Jun 21, 2007
INSTANT-VIEW FECAL OCCULT BLOOD (FOB) RAPID TEST
KHE
Reagent, Occult Blood
104d
Cleared
Jun 20, 2007
GENESISCS COMPONENT CONCENTRATING SYSTEM
JQC
Centrifuges (micro, Ultra, Refrigerated) For Clinical Use
100d
Cleared
Jun 11, 2007
BC-3200 AUTO HEMATOLOGY ANALYZER
GKZ
Counter, Differential Cell
214d
Cleared
Jun 11, 2007
OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROL
GHH
Fibrin Split Products
115d
Cleared
Jun 06, 2007
BD TRITEST CD3/CD4/CD45 WITH BD TRUCOUNT ABSOLUTE COUNT TUBES, MODEL 340402
GKZ
Counter, Differential Cell
43d
Cleared
Jun 06, 2007
BD TRITEST CD3/CD4/CD45, MODEL 340383
GKZ
Counter, Differential Cell
43d
Cleared
May 29, 2007
ASPIRINWORKS TEST KIT (11-DEHYDRO THROMBOXANE B2), MODEL 12136
OBW
11-dehydro Thromboxane B2 Kit, Urinary
315d
Cleared
May 15, 2007
STASIS - I, II AND III
GIZ
Plasma, Control, Normal
403d
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