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
Aug 03, 1984
SALINE, 0.85%W/PRESERVATIVE
KIP
Formulations, Balanced Salt Solutions
21d
Cleared
Aug 03, 1984
DECOLORIZING FLUID
PPM
General Purpose Reagent
21d
Cleared
Aug 02, 1984
EARLY DETECTOR
KHE
Reagent, Occult Blood
310d
Cleared
Jul 27, 1984
PARA-TEK
JPK
Mixture, Hematology Quality Control
102d
Cleared
Jul 27, 1984
MIDAS II AUTOMATIC STAINER
KPA
Slide Stainer, Automated
65d
Cleared
Jul 27, 1984
TECHNICON TEST POINT ASSAYED HEMATOLOGY
JPK
Mixture, Hematology Quality Control
59d
Cleared
Jul 27, 1984
HISTOPAQUE-1077
JCF
Lymphocyte Separation Medium
58d
Cleared
Jul 27, 1984
COULTER AUTOMATIC SAMPLE HANDLER
GKL
Counter, Cell, Automated (particle Counter)
43d
Cleared
Jul 27, 1984
TECHNICON H*1 SYSTEM
GKZ
Counter, Differential Cell
18d
Cleared
Jun 26, 1984
PARA 4
JPK
Mixture, Hematology Quality Control
39d
Cleared
Jun 11, 1984
QUICK-COUNT PLUS 2
GKL
Counter, Cell, Automated (particle Counter)
62d
Cleared
Jun 01, 1984
DIA REPTIN
GIR
Reagent, Russel Viper Venom
60d
Cleared
Jun 01, 1984
DIA FIBRIN
KQJ
System, Fibrinogen Determination
60d
Cleared
Jun 01, 1984
HEPARIN COAGULATION CONTROL PLASMA 1-
JPA
System, Multipurpose For In Vitro Coagulation Studies
53d
Cleared
Jun 01, 1984
OWREN'S VERONAL BUFFERR
JPA
System, Multipurpose For In Vitro Coagulation Studies
50d
Cleared
May 31, 1984
CYANOMETHEMOGLOBIN REAGENT
GIF
Diluent, Blood Cell
43d
Cleared
May 31, 1984
LYSING & HEMOGLOBIN REAGENT
GGK
Products, Red-cell Lysing Products
43d
Cleared
May 31, 1984
RETIC-SET
KQC
Stains, Hematology
64d
Cleared
May 21, 1984
SODIUM CHLORIDE SOLUTION BLOOD CELL
FNW
Pad, Kelly
62d
Cleared
May 11, 1984
ULTRACLONE ECL-01-800 CELL LINE
KIR
Cells, Animal And Human, Cultured
39d
Cleared
May 11, 1984
ULTRACLONE ECL-01-600 CELL LINE
KIR
Cells, Animal And Human, Cultured
39d
Cleared
May 11, 1984
ULTRA CLONE ECL-01-700 CELL LINE
KIR
Cells, Animal And Human, Cultured
39d
Cleared
May 11, 1984
ULTRACLONE ECL-01-500 CELL LINE
KIR
Cells, Animal And Human, Cultured
39d
Cleared
May 11, 1984
ULTRACLONE ECL-01-200 CELL LINE
KIR
Cells, Animal And Human, Cultured
39d
Cleared
May 07, 1984
PARAGON ACID HEMOGLOBIN REAGENT KIT
GKA
Abnormal Hemoglobin Quantitation
129d
Looking for a specific hematology device? Search by device name, K-number or manufacturer.
Search all Hematology 510(k) devices