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
May 22, 2000
NYCOCARD HBA1C GLYCOSYLATED HEMOGLOBIN ASSAY
LCP
Assay, Glycosylated Hemoglobin
245d
Cleared
May 11, 2000
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-6000
GKP
Instrument, Coagulation, Automated
31d
Cleared
May 05, 2000
SERIM LEUKOCYTE ESTERASE TEST STRIPS
LJX
Test, Urine Leukocyte
73d
Cleared
May 05, 2000
THROMBELASTOGRAPH COAGULATION ANALYZER TEG - 5000 SERIES
JPA
System, Multipurpose For In Vitro Coagulation Studies
186d
Cleared
Apr 26, 2000
K-ASSAY AT-III
JBQ
Antithrombin Iii Quantitation
82d
Cleared
Apr 25, 2000
SYSMEX AUTOMATED COAGULATION ANALYZER, MODEL CA-1500
GGP
Test, Qualitative And Quantitative Factor Deficiency
57d
Cleared
Apr 20, 2000
COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSES
GKZ
Counter, Differential Cell
197d
Cleared
Apr 18, 2000
PARA 12 PLUS RETICS
GLQ
Mixture, Control, White-cell And Red-cell Indices
26d
Cleared
Apr 17, 2000
SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200
GGP
Test, Qualitative And Quantitative Factor Deficiency
70d
Cleared
Apr 07, 2000
ACCUCLOT DRVVT SCREEN, CATALOG NO. A6094
GIR
Reagent, Russel Viper Venom
50d
Cleared
Apr 07, 2000
ACCUCLOT DRVVT CONFIRM, CATALOG NO. A62119
GIR
Reagent, Russel Viper Venom
50d
Cleared
Mar 28, 2000
(TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINT
JBP
Activated Whole Blood Clotting Time
106d
Cleared
Mar 27, 2000
RETIC CHEX LINEARITY
JPK
Mixture, Hematology Quality Control
73d
Cleared
Mar 24, 2000
THROMBOSTRATE CONTROL PLASMAS
GGN
Plasma, Coagulation Control
24d
Cleared
Mar 21, 2000
GLYPRO REAGENT, GLYPRO CALIBRATOR, GLYPRO LOW CONTROL, GLYPRO HIGH CONTROL
LCP
Assay, Glycosylated Hemoglobin
54d
Cleared
Mar 15, 2000
ACL 9000 SYSTEM
JPA
System, Multipurpose For In Vitro Coagulation Studies
68d
Cleared
Mar 03, 2000
CELL-CHEX
GJR
Control, Red-cell
53d
Cleared
Mar 03, 2000
FIBRINOGEN CALIBRATOR KIT
GFX
Fibrinogen Standard
71d
Cleared
Feb 18, 2000
PACIFIC HEMOSTASIS THROMBOPLASTIN D
GJS
Test, Time, Prothrombin
77d
Cleared
Feb 16, 2000
GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05
GGC
Control, Plasma, Abnormal
135d
Cleared
Feb 15, 2000
HMP CONTROLS (TAS) RAPIDPOINT
GGN
Plasma, Coagulation Control
68d
Cleared
Feb 10, 2000
I-STAT SYSTEM
JBP
Activated Whole Blood Clotting Time
192d
Cleared
Feb 03, 2000
AVOCET ACUSURE (FOR PATIENT SELF-TESTING) AND AVOCET ACUSURE PRO (FOR PROFESSIONAL USE)
GJS
Test, Time, Prothrombin
71d
Cleared
Feb 01, 2000
GTI-FVIII INHIBITOR ASSAY
GGP
Test, Qualitative And Quantitative Factor Deficiency
104d
Cleared
Jan 28, 2000
ADVANCED D-DIMER
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
148d
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