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
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
Cleared
May 11, 2007
FORSURE ONE STEP FECAL OCCULT BLOOD (FOB) SCREEN CARD TEST
KHE
Reagent, Occult Blood
149d
Cleared
May 11, 2007
COAGUCHEK XS PLUS SYSTEM
GJS
Test, Time, Prothrombin
29d
Cleared
Mar 29, 2007
R&D SICKLE QC CONTROL
GGM
Control, Hemoglobin
52d
Cleared
Mar 29, 2007
HEMOSIL PROCLOT
GGP
Test, Qualitative And Quantitative Factor Deficiency
22d
Cleared
Mar 26, 2007
QWIKCHECK TEST STRIPS- REAGENT STRIPS FOR SEMEN ANALYSIS
POV
Semen Analysis Device
87d
Cleared
Mar 23, 2007
STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
136d
Cleared
Mar 16, 2007
PLASMACON N, PLASMACON L-1, PLASMACON L-2
GGC
Control, Plasma, Abnormal
220d
Cleared
Mar 14, 2007
TINA-QUANT D-DIMER TEST SYSTEM
GHH
Fibrin Split Products
225d
Cleared
Mar 05, 2007
INNOVACON FLIPCARD FECAL OCCULT BLOOD TEST DEVICE
KHE
Reagent, Occult Blood
84d
Cleared
Mar 01, 2007
TRIAGE PROTEIN C CONTROLS AND CALIBRATION VERIFICATION CONTROLS
GGN
Plasma, Coagulation Control
160d
Cleared
Feb 23, 2007
PLATELETWORKS ARACHIDONIC ACID, MODEL PW-ACA
GHR
Reagent, Platelet Aggregation
225d
Cleared
Feb 23, 2007
RETIC-CHEX LINEARITY FOR BC
JPK
Mixture, Hematology Quality Control
32d
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