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.
3297
Total
3290
Cleared
164d
Avg (2y)
1976
Since
3297 Hematology devices
Cleared
Feb 07, 1977
QUAN-8 MULT-COMP FACTOR VIII ASSAY KIT
GGP
Test, Qualitative And Quantitative Factor Deficiency
81d
Cleared
Feb 07, 1977
MICROSAMPLE BLOOD COLLECTION DEVICE
GKH
Apparatus, Automated Blood Cell Diluting
75d
Cleared
Feb 01, 1977
TPC-LYOPHILIZED POOLED HUMAN PLASMA
JPA
System, Multipurpose For In Vitro Coagulation Studies
71d
Cleared
Feb 01, 1977
JTB 700 HEMATOLOGY ANALYZER
JPJ
Red-cell Indices, Calculated
41d
Cleared
Jan 17, 1977
TERASAKI LYMPHOCYTE TRANSPORT KIT
KSR
Container, Empty, For Collection & Processing Of Blood & Blood Components
76d
Cleared
Jan 12, 1977
AGGRECETIN
JOZ
System, Automated Platelet Aggregation
77d
Cleared
Jan 10, 1977
BLOOD CELL PROCESSOR MODEL 2 IBM 2991
GKT
Separator, Automated, Blood Cell, Diagnostic
87d
Cleared
Jan 10, 1977
HEPARIN CONTROL PLASMA
GFO
Activated Partial Thromboplastin
74d
Cleared
Jan 10, 1977
BARBITAL SALINE BUFFER
JCE
Solution, Isotonic
40d
Cleared
Jan 10, 1977
VERONAL BUFFER
JPA
System, Multipurpose For In Vitro Coagulation Studies
40d
Cleared
Jan 10, 1977
TRIS BUFFERED SALINE
JPA
System, Multipurpose For In Vitro Coagulation Studies
40d
Cleared
Jan 10, 1977
TRIS BUFFERED
JPA
System, Multipurpose For In Vitro Coagulation Studies
40d
Cleared
Jan 10, 1977
PHYSIOLOGIC SALINE (0.85%)
JCE
Solution, Isotonic
40d
Cleared
Jan 10, 1977
IMIDAZOLE BUFFER (0.05M)
JPA
System, Multipurpose For In Vitro Coagulation Studies
40d
Cleared
Jan 10, 1977
CALCIUM CHLORIDE (0.025M)
JPA
System, Multipurpose For In Vitro Coagulation Studies
40d
Cleared
Jan 10, 1977
SODIUM CITRATE
GJE
Tray, Blood Collection
40d
Cleared
Dec 30, 1976
WHOLE BLOOD PLATELET COUNTER -2510
GKL
Counter, Cell, Automated (particle Counter)
87d
Cleared
Dec 21, 1976
QUICK CULT SLIDE TEST FECAL OCCULT BLOOD
KHE
Reagent, Occult Blood
11d
Cleared
Dec 09, 1976
ISOTONIC DILUENT AF
GGK
Products, Red-cell Lysing Products
7d
Cleared
Dec 06, 1976
DONORMATIC (BLOOD COLLECTION DEVICE)
KSQ
Device, Blood Mixing And Blood Weighing
67d
Cleared
Nov 24, 1976
AUTO-FI COAGULATION INSTRUMENT
JPA
System, Multipurpose For In Vitro Coagulation Studies
78d
Cleared
Nov 23, 1976
DOUBLE ELUTRA-PACK UNIT
KSW
System, Processing For Frozen Blood
27d
Cleared
Nov 11, 1976
HA/3 HEMATOLOGY ANALYZER
GKL
Counter, Cell, Automated (particle Counter)
69d
Cleared
Nov 09, 1976
HA/5 HEMATOLOGY ANALYZER
GKL
Counter, Cell, Automated (particle Counter)
67d
Cleared
Oct 29, 1976
UNIFORM DROP SIZE PASTEUR TYPE PIPETS
GJG
Pipette, Quantitative, Hematology
32d
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