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
2620 Hematology devices
Cleared
Dec 17, 1984
COULTER CHECK SAMPLE UNASSAYED HEMATOLOG
JPK
Mixture, Hematology Quality Control
81d
Cleared
Dec 12, 1984
ORTHO BRAIN THROMBOPLASTIN DILUENT
GJS
Test, Time, Prothrombin
96d
Cleared
Dec 11, 1984
WAKO AUTOMATED REAGENTS FOR HITACHI 705
CJW
Bromcresol Purple Dye-binding, Albumin
144d
Cleared
Dec 10, 1984
ABL300 ACID BASE LABORATORY
CHL
Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
34d
Cleared
Dec 05, 1984
COULTER COUNTER MODEL M4
GKL
Counter, Cell, Automated (particle Counter)
104d
Cleared
Dec 05, 1984
COLOSCREEN SELF-TEST
KHE
Reagent, Occult Blood
100d
Cleared
Nov 30, 1984
COUNT-A-PART PLUS
JPK
Mixture, Hematology Quality Control
213d
Cleared
Nov 30, 1984
HEPARIN ACA ANALYTICAL TEST PACK
KFF
Assay, Heparin
108d
Cleared
Nov 30, 1984
HEPARIN CALIBRATOR ACA
KFF
Assay, Heparin
108d
Cleared
Nov 19, 1984
FACTOR IX DEFICIENT PLASMA, B9D -
GGP
Test, Qualitative And Quantitative Factor Deficiency
96d
Cleared
Nov 19, 1984
FACTOR X DEFICIENT PLASMA, BLOD HUMAN
GGP
Test, Qualitative And Quantitative Factor Deficiency
88d
Cleared
Nov 19, 1984
FACTOR XI DEFICIENT PLASMA B11D
GGP
Test, Qualitative And Quantitative Factor Deficiency
76d
Cleared
Nov 19, 1984
FACTOR XII DEFICIENT PLASMA B12D
GGP
Test, Qualitative And Quantitative Factor Deficiency
75d
Cleared
Nov 13, 1984
COULTER COUNTER MODEL ZM
GKL
Counter, Cell, Automated (particle Counter)
92d
Cleared
Nov 13, 1984
MICRO HEMATOCRIT CAPILLARY TUBES
GIO
Tube, Collection, Capillary Blood
41d
Cleared
Nov 01, 1984
CBC-PLT-4 WHOLE BLOOD CONTROL/MULTIPLE
JPK
Mixture, Hematology Quality Control
21d
Cleared
Oct 31, 1984
ARTAP ARTERIAL BLOOD SAMPLING DEVICE
CBT
Arterial Blood Sampling Kit
64d
Cleared
Oct 31, 1984
ULTRAXLONE ECL-01-1000 CELL LINE
KIR
Cells, Animal And Human, Cultured
50d
Cleared
Oct 31, 1984
ULTRACLONE ECL-01-2100 CELL LINE
KIR
Cells, Animal And Human, Cultured
50d
Cleared
Oct 31, 1984
ULTRACLONE ECL-01-1100
KIR
Cells, Animal And Human, Cultured
50d
Cleared
Oct 31, 1984
SIGMA SUDAN BLACK REAGENT 380-1
HZZ
Sudan Black B
43d
Cleared
Oct 30, 1984
RETIC-SET
KQC
Stains, Hematology
46d
Cleared
Oct 30, 1984
SIGMA PERIODIC ACID-SCHIFF STAIN 395
HZT
Reagent, Schiff
35d
Cleared
Oct 23, 1984
CST
JCF
Lymphocyte Separation Medium
97d
Cleared
Oct 23, 1984
RETIC-CHEX
JPK
Mixture, Hematology Quality Control
77d
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