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
Aug 27, 2002
PROTEIN S AC
GGP
Test, Qualitative And Quantitative Factor Deficiency
43d
Cleared
Aug 27, 2002
COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS
JBQ
Antithrombin Iii Quantitation
25d
Cleared
Aug 12, 2002
MAGELLAN AUTOLOGUS PLATELET SEPARATOR, MAG100, MAGELLAN AUTOLOGOUS PLATELET SEPARATOR DEISPOSABLE KIT, MKT300
JQC
Centrifuges (micro, Ultra, Refrigerated) For Clinical Use
63d
Cleared
Aug 07, 2002
MDA D-DIMER
GHH
Fibrin Split Products
61d
Cleared
Aug 07, 2002
COAMATIC AT-400
JBQ
Antithrombin Iii Quantitation
33d
Cleared
Jul 29, 2002
MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER, MODEL 6605632
GKZ
Counter, Differential Cell
26d
Cleared
Jul 12, 2002
PLATELET CONCENTRATE SEPARATION KIT FOR CELSEP CENTRIFUGE SYSTEM
LXG
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
30d
Cleared
Jun 27, 2002
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL #CA-7000
GKP
Instrument, Coagulation, Automated
93d
Cleared
Jun 25, 2002
MODIFICATION TO PARA 5X
JPK
Mixture, Hematology Quality Control
14d
Cleared
Jun 24, 2002
MEDICA EASYQC HEMATOCRIT CONTROL
GLK
Control, Hematocrit
13d
Cleared
Jun 17, 2002
INSTANT-VIEW FECAL OCCULT BLOOD RAPID TEST
KHE
Reagent, Occult Blood
45d
Cleared
Jun 11, 2002
COULTER CELLPREP
GKH
Apparatus, Automated Blood Cell Diluting
62d
Cleared
May 23, 2002
ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770
JBP
Activated Whole Blood Clotting Time
63d
Cleared
May 16, 2002
HEMOSIL HIGH ABNORMAL CONTROL ASSAYED
GGN
Plasma, Coagulation Control
48d
Cleared
May 14, 2002
G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE
JPD
Hemoglobin A2 Quantitation
90d
Cleared
May 14, 2002
AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROL
GLK
Control, Hematocrit
78d
Cleared
May 14, 2002
HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED)
GGN
Plasma, Coagulation Control
46d
Cleared
May 14, 2002
HEMOSIL NORMAL CONTROL (ASSAYED)
GGN
Plasma, Coagulation Control
46d
Cleared
Apr 15, 2002
LYPHOCHEK HEMOSTASIS, MODELS 798, 799
GGC
Control, Plasma, Abnormal
28d
Cleared
Apr 04, 2002
CAL-CHEX CD PLUS
KRX
Calibrator For Cell Indices
51d
Cleared
Mar 28, 2002
HEMOCHRON JR. SIGNATURE +
JPA
System, Multipurpose For In Vitro Coagulation Studies
16d
Cleared
Feb 06, 2002
SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL
GGC
Control, Plasma, Abnormal
26d
Cleared
Feb 06, 2002
R & D BODY FLUID CONTROL
JPK
Mixture, Hematology Quality Control
14d
Cleared
Feb 01, 2002
BD VACUTAINER SAFETY COAGULATION TUBE
JKA
Tubes, Vials, Systems, Serum Separators, Blood Collection
60d
Cleared
Jan 22, 2002
R&D RET-LINE KIT
JPK
Mixture, Hematology Quality Control
60d
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