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
Dec 30, 1988
DADE FACTOR IX CHROMOGENIC ASSAY
GGP
Test, Qualitative And Quantitative Factor Deficiency
60d
Cleared
Dec 30, 1988
COAG-A-MATE XC/XC PLUS VERSION D.00 SOFTWARE
JPA
System, Multipurpose For In Vitro Coagulation Studies
22d
Cleared
Dec 28, 1988
THROMBIN-PREST REAGENT KIT
GJA
Test, Thrombin Time
71d
Cleared
Dec 28, 1988
FIBRI-PREST/THROMBIN-PREST CONTROLS
GJA
Test, Thrombin Time
71d
Cleared
Dec 28, 1988
KD ACTIVATED PARTIAL THROMBOPLASTIN TIME REAGENT
GFO
Activated Partial Thromboplastin
64d
Cleared
Dec 28, 1988
COULTER STKS
GKZ
Counter, Differential Cell
19d
Cleared
Dec 28, 1988
FACSMATE SAMPLE HANDLING DEVICE
GKL
Counter, Cell, Automated (particle Counter)
16d
Cleared
Dec 27, 1988
LABILE LYSING REAGENT
LCP
Assay, Glycosylated Hemoglobin
75d
Cleared
Dec 20, 1988
TURBOX ANTITHROMBIN III
JBQ
Antithrombin Iii Quantitation
81d
Cleared
Dec 20, 1988
TURBOX FIBRINOGEN
KQJ
System, Fibrinogen Determination
81d
Cleared
Dec 01, 1988
TENDERFOOT
FMK
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
72d
Cleared
Nov 23, 1988
BERICHROM(R) ANTITHROMBIN III
JBQ
Antithrombin Iii Quantitation
89d
Cleared
Nov 22, 1988
GHB SAMPLE PAPER
LCP
Assay, Glycosylated Hemoglobin
277d
Cleared
Nov 22, 1988
MSI-CAL 7
KRZ
Calibrator For Hemoglobin And Hematocrit Measurement
84d
Cleared
Nov 22, 1988
MSI-CAL 16
KRZ
Calibrator For Hemoglobin And Hematocrit Measurement
84d
Cleared
Nov 22, 1988
MSI-CAL 8
KRZ
Calibrator For Hemoglobin And Hematocrit Measurement
84d
Cleared
Nov 01, 1988
ORTHO FACTOR XII DEFICIENT PLASMA
GJT
Plasma, Coagulation Factor Deficient
64d
Cleared
Nov 01, 1988
ORTHO OWREN'S BUFFER
JPA
System, Multipurpose For In Vitro Coagulation Studies
64d
Cleared
Nov 01, 1988
ORTHO FACTOR X DEFICIENT PLASMA
GJT
Plasma, Coagulation Factor Deficient
64d
Cleared
Nov 01, 1988
ORTHO FACTOR XI DEFICIENT PLASMA
GJT
Plasma, Coagulation Factor Deficient
64d
Cleared
Nov 01, 1988
ORTHO FACTOR VII DEFICIENT PLASMA
GJT
Plasma, Coagulation Factor Deficient
64d
Cleared
Oct 31, 1988
KD 0.1 M SODIUM CITRATE SOLUTION
JPA
System, Multipurpose For In Vitro Coagulation Studies
67d
Cleared
Oct 31, 1988
KD 0.02 M CALCIUM CHLORIDE SOLUTION
JPA
System, Multipurpose For In Vitro Coagulation Studies
67d
Cleared
Oct 31, 1988
KD ONE-STAGE PROTHROMBIN TIME TEST
JPA
System, Multipurpose For In Vitro Coagulation Studies
67d
Cleared
Oct 06, 1988
HEMOGLOBIN
GJZ
Cyanomethemoglobin Reagent And Standard Solution
38d
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