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
2619 Hematology devices
Cleared
Aug 09, 1991
SIMPLATE PEDIATRIC
JCA
Device, Bleeding Time
113d
Cleared
Aug 09, 1991
ACS LIQUID THROMBOPLASTIN
GJS
Test, Time, Prothrombin
88d
Cleared
Jul 26, 1991
SYSMEX F-810
GKL
Counter, Cell, Automated (particle Counter)
149d
Cleared
Jul 26, 1991
SYSMEX F-610
GKL
Counter, Cell, Automated (particle Counter)
149d
Cleared
Jul 26, 1991
SYSMEX F-310
GKL
Counter, Cell, Automated (particle Counter)
149d
Cleared
Jul 24, 1991
HEPARIN ADSORBENT
JPA
System, Multipurpose For In Vitro Coagulation Studies
76d
Cleared
Jul 17, 1991
HEMOCHRON(R) APTT, MODIFICATION
GFO
Activated Partial Thromboplastin
86d
Cleared
Jul 17, 1991
PROTHROMBIN TIME (PT) BY HEMOCHRON, MODIFICATION
GJS
Test, Time, Prothrombin
86d
Cleared
Jul 17, 1991
SURGICUTT-BLEEDING TIME DEVICE, MODIFICATION
JCA
Device, Bleeding Time
86d
Cleared
Jul 17, 1991
TENDERFOOT(R), MODIFICATION
FMK
Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
86d
Cleared
Jul 17, 1991
PX COULTER(R) CELL CONTROL
JPK
Mixture, Hematology Quality Control
64d
Cleared
Jul 11, 1991
HEMOGLOBIN REAGENT
GKR
System, Hemoglobin, Automated
140d
Cleared
Jul 09, 1991
ABL520 BLOOD GAS SYSTEM
GHS
Assay, Carboxyhemoglobin
132d
Cleared
Jul 09, 1991
3K-CAL HEMATOLOGY CALIBRATOR/MULTIPLE
KRX
Calibrator For Cell Indices
42d
Cleared
Jul 03, 1991
COLOCARE
KHE
Reagent, Occult Blood
226d
Cleared
Jul 03, 1991
COLOSCREEN
KHE
Reagent, Occult Blood
114d
Cleared
Jun 17, 1991
COULTER(R) MH010
GKZ
Counter, Differential Cell
81d
Cleared
Jun 13, 1991
ANEMIA I, II
JJY
Multi-analyte Controls, All Kinds (assayed)
41d
Cleared
Jun 11, 1991
DADE(R) PROTEIN C ABNORMAL CONTRAL
GGC
Control, Plasma, Abnormal
43d
Cleared
Jun 10, 1991
LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL
JCM
Control, Hemoglobin, Abnormal
75d
Cleared
May 28, 1991
STAK-CHEX
JCN
Control, Cell Counter, Normal And Abnormal
50d
Cleared
May 20, 1991
ORTHO MUNE OKT3,4, AND 8 MONOCLONAL ANTIBODY
GKZ
Counter, Differential Cell
248d
Cleared
May 20, 1991
EPINEPHRINE REAGENT, CAT. NO. 5367
GHR
Reagent, Platelet Aggregation
94d
Cleared
May 20, 1991
COLLAGEN REAGENT CAT. NO. 5368
GHR
Reagent, Platelet Aggregation
89d
Cleared
May 20, 1991
ADP REAGENT
GHR
Reagent, Platelet Aggregation
84d
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