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
Aug 04, 1977
AUTO DIFFERENTIAL CELL COUNTER SYSTEM
GKZ
Counter, Differential Cell
178d
Cleared
Aug 04, 1977
BLOOD GROUPING SYS., BG-9
KSZ
System, Test, Automated Blood Grouping And Antibody
45d
Cleared
Aug 04, 1977
LIQUAEMIB SODIUM PRESERVATIVE, ETC.
GIM
Tubes, Vacuum Sample, With Anticoagulant
21d
Cleared
Aug 04, 1977
LIQUAEMIN SODIUM, HEPARIN SODIUM ETC.
GIM
Tubes, Vacuum Sample, With Anticoagulant
21d
Cleared
Aug 03, 1977
ICROTAINEO BRAND TUBE
GJE
Tray, Blood Collection
9d
Cleared
Aug 02, 1977
WHOLE BLOOD GAS CONTROL
JJS
Controls For Blood-gases, (assayed And Unassayed)
69d
Cleared
Jul 11, 1977
EMATOLOGY DILUENT RESERVOIR CLOSURE
GHO
Hemocytometer
41d
Cleared
Jul 11, 1977
LANCER CAPILLARY BLOOD SERUM SEPARATOR
GIO
Tube, Collection, Capillary Blood
41d
Cleared
Jul 05, 1977
TUBE, STAIN, RETICULOCYTE, LARC
KFC
Methylene Blue, Tissue Stain
64d
Cleared
Jun 24, 1977
LATELET DETERMIBATION KIT, UL 800
GJP
Control, Platelet
79d
Cleared
May 06, 1977
HEMALOG 8/90
GKL
Counter, Cell, Automated (particle Counter)
28d
Cleared
Apr 08, 1977
MNITROL HEMOTOL. REF. AND CONTROL
JPK
Mixture, Hematology Quality Control
39d
Cleared
Apr 08, 1977
LATELET DETERMIN. KIT, CAT NO. 2521
GKL
Counter, Cell, Automated (particle Counter)
39d
Cleared
Apr 06, 1977
LYMPHOCYTE TYPING, NEGATIVE CONTROL
LGO
Test, Leukocyte Typing
155d
Cleared
Apr 06, 1977
LYMPHOCYTE TYPING, POSITIVE CONTROL
LGO
Test, Leukocyte Typing
155d
Cleared
Mar 28, 1977
ULTRA LOGIC 800 HEMATOLOGY ANA. (UL-800)
GKL
Counter, Cell, Automated (particle Counter)
98d
Cleared
Mar 21, 1977
LATELET, CONTROL, NORMAL & ABNORMAL
JPK
Mixture, Hematology Quality Control
21d
Cleared
Mar 14, 1977
RH CONTROL DILUENT
KSZ
System, Test, Automated Blood Grouping And Antibody
46d
Cleared
Mar 01, 1977
SIMPLATE
JCA
Device, Bleeding Time
78d
Cleared
Feb 28, 1977
PLATELET CONTROL, NORMAL & ABNORMAL
JPK
Mixture, Hematology Quality Control
42d
Cleared
Feb 18, 1977
HPC TM (HEPARINIZED PLASMA CONTROL)
GGC
Control, Plasma, Abnormal
21d
Cleared
Feb 16, 1977
PLATELET-CHEX-HUMAN
JPK
Mixture, Hematology Quality Control
41d
Cleared
Feb 16, 1977
COUNTER, BLOOD CELL & HEMATOCRIT
GKL
Counter, Cell, Automated (particle Counter)
37d
Cleared
Feb 07, 1977
QUAN-8 MULT-COMP FACTOR VIII ASSAY KIT
GGP
Test, Qualitative And Quantitative Factor Deficiency
81d
Cleared
Feb 01, 1977
TPC-LYOPHILIZED POOLED HUMAN PLASMA
JPA
System, Multipurpose For In Vitro Coagulation Studies
71d
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