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
2617 Hematology devices
Cleared
Jul 28, 1999
CRYOCHECK LA SURE, MODEL SUR25-10
GIR
Reagent, Russel Viper Venom
155d
Cleared
Jul 26, 1999
CARESIDE PT
GJS
Test, Time, Prothrombin
117d
Cleared
Jul 23, 1999
CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML)
GIR
Reagent, Russel Viper Venom
150d
Cleared
Jul 12, 1999
IMMULITE EPO, MODEL #'S LKEPZ & LKEP1
GGT
Assay, Erythropoietin
301d
Cleared
Jul 09, 1999
CELL-DYN 3500 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION (IRF), CELL-DYN 3700 SYSTEM WITH IMMATURE RETICULOCYTE FRACTION
GKZ
Counter, Differential Cell
60d
Cleared
Jul 01, 1999
THERMAL ANGEL
BSB
Warmer, Blood, Non-electromagnetic Radiation
182d
Cleared
Jul 01, 1999
EXCELL 22
GKZ
Counter, Differential Cell
59d
Cleared
Jun 23, 1999
CELL-DYN 1200 SYSTEM
GKZ
Counter, Differential Cell
79d
Cleared
Jun 21, 1999
PACIFIC HEMOSTASIS THROMBOSCREEN 200
KQG
Instrument, Coagulation
63d
Cleared
Jun 21, 1999
HYDRAGEL HEMOGLOBIN(E), MINI HEMOGLOBIN(E), 7 HEMOGLOBIN(E), 15 HEMOGLOBIN(E), ACID(E) HEMOGLOBIN(E), MINI ACID(E) HEMO)
JBD
System, Analysis, Electrophoretic Hemoglobin
68d
Cleared
Jun 21, 1999
DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE-CY5, CLONE UCHT1 & DAKO MOUSE ANTI-HUMAN T-CELL, CD3/RPE, CLONE UCHT1
GKZ
Counter, Differential Cell
60d
Cleared
Jun 21, 1999
MOUSE IGG1 NEGATIVE CONTROLS
GKZ
Counter, Differential Cell
56d
Cleared
Jun 17, 1999
SEDRITE PLUS ERYTHROCYTE SEDIMENTATION RATE
JPK
Mixture, Hematology Quality Control
15d
Cleared
Jun 10, 1999
VARIANT II B-THALASSEMIA
JPD
Hemoglobin A2 Quantitation
69d
Cleared
Jun 07, 1999
CRYO CHECK FACTOR 2 DEFICIENT PLASMA, MODELS FDPO2-10, FDP02-15
GJT
Plasma, Coagulation Factor Deficient
88d
Cleared
Jun 01, 1999
COAG-A-MATE MAX
GKP
Instrument, Coagulation, Automated
61d
Cleared
May 28, 1999
GBACT + KIT
JBP
Activated Whole Blood Clotting Time
191d
Cleared
May 28, 1999
SMARTPREP CENTRIFUGE SYSTEM
JQC
Centrifuges (micro, Ultra, Refrigerated) For Clinical Use
32d
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
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