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
May 27, 1999
CRIT-SCAN II MONITOR
GKF
Instrument, Hematocrit, Automated
230d
Cleared
May 14, 1999
TAS ANALYZER, MODEL 1009
JPA
System, Multipurpose For In Vitro Coagulation Studies
81d
Cleared
May 11, 1999
DBEST OCCULT BLOOD TEST KIT
KHE
Reagent, Occult Blood
201d
Cleared
May 11, 1999
ASTORIA-PACIFIC SPOTCHECK G6PD KIT 50 HR, MODEL 80-3000-13K
JBL
Glucose-6-phosphate Dehydrogenase (erythrocytic), Quantitative
50d
Cleared
May 11, 1999
COULTER Z2 ANALYZER
GKL
Counter, Cell, Automated (particle Counter)
41d
Cleared
May 03, 1999
HEMOCHRON RESPONSE
KQG
Instrument, Coagulation
213d
Cleared
Apr 26, 1999
RETICONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS
GKZ
Counter, Differential Cell
83d
Cleared
Apr 21, 1999
LYPOCHEK COAGULATION CONTROL, MODEL NOS. 787, 788, 789
GGN
Plasma, Coagulation Control
37d
Cleared
Apr 13, 1999
COAGUCHEK PRO SYSTEM, APTT TEST CARTRIDGES FOR COAGUCHEK PRO SYSTEM, APTT CONTROLS FOR COAGUCHEK PRO SYSTEM, COAGUCHEK P
JPA
System, Multipurpose For In Vitro Coagulation Studies
161d
Cleared
Apr 13, 1999
TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS WITH CYTO-STAT TETRACHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 MONOCLA
GKZ
Counter, Differential Cell
84d
Cleared
Apr 13, 1999
HEMOCHRON ELECTRONIC SYSTEM VERIFICATION TUBE
JPA
System, Multipurpose For In Vitro Coagulation Studies
60d
Cleared
Apr 08, 1999
IL TEST LAC SCREEN (CLAIMS ADDED TO ACL FUTURA), IL TEST LAC CONFIRM (CLAIMS ADDAD TO ACL FUTURA)
GIR
Reagent, Russel Viper Venom
66d
Cleared
Apr 01, 1999
COULTER AC T DIFF 2 ANALYZER
GKZ
Counter, Differential Cell
55d
Cleared
Mar 31, 1999
VEGA RETIC AUTOMATED HEMATOLOGY ANALYZER
GKZ
Counter, Differential Cell
58d
Cleared
Mar 23, 1999
ADVANTAGE CHEMILUMINESCENCE ERYTHROPOIETIN IMMUNOASSAY
GGT
Assay, Erythropoietin
391d
Cleared
Mar 19, 1999
AUTOMARQER
POV
Semen Analysis Device
58d
Cleared
Mar 18, 1999
CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML)
GJT
Plasma, Coagulation Factor Deficient
49d
Cleared
Mar 16, 1999
IMMUNO-TROL CONTROL CELLS
JPK
Mixture, Hematology Quality Control
112d
Cleared
Mar 09, 1999
GTI-PF4 ELISA
LCO
Platelet Factor 4 Radioimmunoassay
165d
Cleared
Feb 17, 1999
CBC-5D HEMATOLOGY CONTROL
JPK
Mixture, Hematology Quality Control
170d
Cleared
Feb 17, 1999
PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR VIII DEFICIENT PLASMA
GJT
Plasma, Coagulation Factor Deficient
41d
Cleared
Feb 11, 1999
DS30 HCY HOMOCYSTEINE ASSAY KIT
LPS
Urinary Homocystine (nonquantitative) Test System
248d
Cleared
Jan 28, 1999
HEMOCHEK SAMPLE COLLECTION KIT
LCP
Assay, Glycosylated Hemoglobin
38d
Cleared
Jan 13, 1999
CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5ML)
GJT
Plasma, Coagulation Factor Deficient
287d
Cleared
Jan 13, 1999
CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5ML)
GJT
Plasma, Coagulation Factor Deficient
287d
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