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 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 23, 2002
ENOXAPARIN TEST CARD
KFF
Assay, Heparin
323d
Cleared
Aug 14, 2002
BIOTEST HEMOGLOBIN MEASURING SYSTEM
GKR
System, Hemoglobin, Automated
162d
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 29, 2002
PENTRA 120/PENTRA 120 RETIC OPTIONS SPS, MODEL PENTRA 120
GKZ
Counter, Differential Cell
24d
Cleared
Jul 23, 2002
VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG COAGULATION CONTROL
GGN
Plasma, Coagulation Control
29d
Cleared
Jul 17, 2002
BAYER RAPIDPOINT 405 SYSTEM
GKR
System, Hemoglobin, Automated
142d
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
SYSMEX XT-SERIES, MODEL XT-2000I AND XT-1800I
GKZ
Counter, Differential Cell
67d
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 14, 2002
HEMOGLOBIN A1C CONTROL
LCP
Assay, Glycosylated Hemoglobin
37d
Cleared
Jun 13, 2002
DEROYAL SURGICAL, UMBILICUP
KSR
Container, Empty, For Collection & Processing Of Blood & Blood Components
98d
Cleared
Jun 12, 2002
ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - ASA (RPFA-ASA)
JOZ
System, Automated Platelet Aggregation
302d
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
MODIFICATION TO ULTEGRA SYSTEM RAPID PLATELET FUNCTION ASSAY - TRAP (RPFA-TRAP)
JOZ
System, Automated Platelet Aggregation
197d
Cleared
May 16, 2002
HEMOSIL HIGH ABNORMAL CONTROL ASSAYED
GGN
Plasma, Coagulation Control
48d
Cleared
May 15, 2002
VITAL SCIENTIFIC PT WITH CALCIUM
GJS
Test, Time, Prothrombin
61d
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