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
2621 Hematology devices
Cleared
Jan 15, 1981
LKB-WALLACE 1250 LUMINOMETER
JJQ
Colorimeter, Photometer, Spectrophotometer For Clinical Use
34d
Cleared
Jan 09, 1981
VITAMIN B12 (57CO) RADIOIMMUNOASSAY
CDD
Radioassay, Vitamin B12
119d
Cleared
Jan 09, 1981
HELENA HBA2 QUIK COLUMN METHOD
JPD
Hemoglobin A2 Quantitation
30d
Cleared
Dec 31, 1980
CRC(CYANMETHEMOGLOBIN REAGENT CONCENT
KHG
Whole Blood Hemoglobin Determination
106d
Cleared
Dec 30, 1980
HEMESPEC II
GKR
System, Hemoglobin, Automated
32d
Cleared
Dec 30, 1980
HELENA HEMESPEC II TOTAL HEMOGLOBIN MET.
GKR
System, Hemoglobin, Automated
32d
Cleared
Dec 22, 1980
CORNING NORMAL GLYCOSYLATED HEMOGLOBIN
JBD
System, Analysis, Electrophoretic Hemoglobin
35d
Cleared
Dec 22, 1980
HELENA AT-III QUIPLATE PROCEDURE
JBQ
Antithrombin Iii Quantitation
34d
Cleared
Dec 11, 1980
PLATELET COUNTING KIT
GKL
Counter, Cell, Automated (particle Counter)
49d
Cleared
Dec 11, 1980
GLYCOHEMOGLOBIN IN WHOLE BLOOD
LCP
Assay, Glycosylated Hemoglobin
41d
Cleared
Dec 11, 1980
PARAGON HEMOGLOBIN ELECTRO. REAG. KIT
JBD
System, Analysis, Electrophoretic Hemoglobin
31d
Cleared
Dec 10, 1980
AMES SERA-PAK URIC ACID REAGENT KIT
KNK
Acid, Uric, Uricase (colorimetric)
40d
Cleared
Dec 01, 1980
VON WILLEBRAND FACTOR ASSAY
GGP
Test, Qualitative And Quantitative Factor Deficiency
66d
Cleared
Nov 12, 1980
AB-TROL COAGULATION CONTROL
GGW
Test, Time, Partial Thromboplastin
58d
Cleared
Nov 12, 1980
CBC PLT-4
JPK
Mixture, Hematology Quality Control
57d
Cleared
Nov 12, 1980
PLT-4 SIZE-CHECK
JPK
Mixture, Hematology Quality Control
57d
Cleared
Nov 12, 1980
CK-MB(IMMUNOLOGICAL)
JHS
Differential Rate Kinetic Method, Cpk Or Isoenzymes
28d
Cleared
Nov 12, 1980
GAMMA LEWIS BLOOD GROUP SUBSTANCE
KSX
Substance, Blood Grouping Of Non-human Origin For In Vitro Diagnostic Use
28d
Cleared
Nov 12, 1980
GAMMA PI BLOOD GROUP SUBSTANCE
KSX
Substance, Blood Grouping Of Non-human Origin For In Vitro Diagnostic Use
28d
Cleared
Oct 31, 1980
GAMBRO HEMOFREEZE-BAG
KSR
Container, Empty, For Collection & Processing Of Blood & Blood Components
177d
Cleared
Oct 31, 1980
CELLTRIFUGE II
GKT
Separator, Automated, Blood Cell, Diagnostic
157d
Cleared
Oct 23, 1980
HGB3 (1:251)
GKR
System, Hemoglobin, Automated
37d
Cleared
Oct 20, 1980
HEPA-SHURE -L
JJK
Oncometer, Plasma, For Clinical Use
46d
Cleared
Oct 10, 1980
AUTOLET
JCA
Device, Bleeding Time
72d
Cleared
Oct 10, 1980
FIBRIN(OGEN) DEGRADATION PRODUCTS(FDP)
GHH
Fibrin Split Products
70d
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