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
2622 Hematology devices
Cleared
Jan 11, 1980
THROMBOKINETIC FIBRINOGEN ASSAY
KQJ
System, Fibrinogen Determination
30d
Cleared
Dec 31, 1979
SANDARE CYANMETHEMOGLOBIN STANDARD
KRZ
Calibrator For Hemoglobin And Hematocrit Measurement
40d
Cleared
Dec 31, 1979
PLATELET-CHEX FOR BLOOD CENTERS
JPK
Mixture, Hematology Quality Control
28d
Cleared
Dec 31, 1979
HELENA FACTOR IX DEFICIENT SUBSTRATE
GGP
Test, Qualitative And Quantitative Factor Deficiency
28d
Cleared
Dec 31, 1979
HELENA FACTOR XI DEFICIENT SUBSTRATE
GGP
Test, Qualitative And Quantitative Factor Deficiency
28d
Cleared
Dec 31, 1979
VOLU-SOL NMB RETICULOCYTE STAIN
KQC
Stains, Hematology
27d
Cleared
Dec 31, 1979
SANDARE CYANMETHEMOGLOBIN REAGENT
KHG
Whole Blood Hemoglobin Determination
27d
Cleared
Dec 31, 1979
HELENA FACTOR V DEFICIENT SUBSTRATE
GGP
Test, Qualitative And Quantitative Factor Deficiency
27d
Cleared
Dec 31, 1979
HELENA FACTOR X DEFICIENT SUBSTRATE
GGP
Test, Qualitative And Quantitative Factor Deficiency
27d
Cleared
Dec 31, 1979
HELENA FACTOR VII DEFICIENT SUB. PLASMA
GGP
Test, Qualitative And Quantitative Factor Deficiency
26d
Cleared
Dec 27, 1979
HELENA FACTOR II DEFICIENT SUB. PLASMA
GGP
Test, Qualitative And Quantitative Factor Deficiency
38d
Cleared
Dec 04, 1979
SANDARE HEMOGLOBIN CONTROLS
JPK
Mixture, Hematology Quality Control
32d
Cleared
Dec 04, 1979
NORM-TROL
JPA
System, Multipurpose For In Vitro Coagulation Studies
18d
Cleared
Dec 04, 1979
HELENA FACTOR VIII DEFICIENT SUB. PLASMA
GGP
Test, Qualitative And Quantitative Factor Deficiency
15d
Cleared
Nov 20, 1979
COUITER/CMS ISOTONIC BLOOD BANK SALINE
JCE
Solution, Isotonic
32d
Cleared
Nov 05, 1979
PHADECODE XA INHIBITOR ASSAY
JBQ
Antithrombin Iii Quantitation
27d
Cleared
Nov 05, 1979
LANCER COAGENT APTT KIT
GGW
Test, Time, Partial Thromboplastin
24d
Cleared
Nov 05, 1979
FISHER DIAGNOSTICS HEMATOLOGY CONTROLS
JPK
Mixture, Hematology Quality Control
21d
Cleared
Oct 30, 1979
COULTER DIFF3 SYS. (COULTER #7400003)
GKZ
Counter, Differential Cell
35d
Cleared
Oct 30, 1979
VOLU-SOL STAT STAIN
IAF
Wright's Stain
21d
Cleared
Oct 23, 1979
EMPTY TRANSFER BAG
KSR
Container, Empty, For Collection & Processing Of Blood & Blood Components
56d
Cleared
Oct 17, 1979
A-GENT GLYCOSPEC
LCP
Assay, Glycosylated Hemoglobin
55d
Cleared
Oct 11, 1979
COUNTER-CHECK PLUS
JPK
Mixture, Hematology Quality Control
36d
Cleared
Oct 11, 1979
COUNTER-CHECK PLUS NORMAL, HIGH ABN.
JPK
Mixture, Hematology Quality Control
34d
Cleared
Oct 11, 1979
ORTHO ANTIBODY ENHANCEMENT SOLUTION
KSG
Media, Potentiating For In Vitro Diagnostic Use
30d
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