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
Dec 01, 1992
CLOTTING FACTOR V DEFICIENT PLASMA
GJT
Plasma, Coagulation Factor Deficient
92d
Cleared
Dec 01, 1992
NEOTHROMITIN(R)
GPO
Antigen, Cf, Typhus Fever Group
92d
Cleared
Dec 01, 1992
CLIBRATION PLASMAS
GGN
Plasma, Coagulation Control
92d
Cleared
Dec 01, 1992
CONTROL PLASMA P
GGC
Control, Plasma, Abnormal
92d
Cleared
Dec 01, 1992
FILTERMATE UNIVERSAL HARVESTER
JTC
Device, Microtiter Diluting/dispensing
63d
Cleared
Nov 17, 1992
CRITERION, HEMOCUE B-HEMOGLOBIN CONTROL
GGM
Control, Hemoglobin
223d
Cleared
Nov 16, 1992
ENZYGNOST F 1+2
MIF
Prothrombin Fragment 1.2
151d
Cleared
Nov 16, 1992
QC-CHEX
JPK
Mixture, Hematology Quality Control
102d
Cleared
Nov 16, 1992
STANDARD HUMAN PLASMA
JPA
System, Multipurpose For In Vitro Coagulation Studies
77d
Cleared
Nov 16, 1992
GLYCOMAT GREEN HBA2 ESTIMATION REAGENT KIT
JPD
Hemoglobin A2 Quantitation
73d
Cleared
Oct 26, 1992
COAG-CONTROL [N] KIT
GGN
Plasma, Coagulation Control
171d
Cleared
Oct 26, 1992
IL TEST PT FIBRINOGEN HS
GIS
Test, Fibrinogen
82d
Cleared
Oct 19, 1992
PLATELIN L
GFO
Activated Partial Thromboplastin
210d
Cleared
Oct 16, 1992
MINUTEX D-DIMER LATEX TEST
GHH
Fibrin Split Products
246d
Cleared
Oct 14, 1992
COULTER MULTI-Q-PREP
GKH
Apparatus, Automated Blood Cell Diluting
90d
Cleared
Oct 09, 1992
SPECTROLYSE/PL PAI KIT
GGP
Test, Qualitative And Quantitative Factor Deficiency
122d
Cleared
Oct 05, 1992
PROPPER SUPER SERACULT(R)
KHE
Reagent, Occult Blood
174d
Cleared
Sep 29, 1992
IMX(R) GLYCATED HEMOGLOBIN
LCP
Assay, Glycosylated Hemoglobin
166d
Cleared
Sep 29, 1992
THROMBIN CLOT TIME TEST PROCEDURE
GJA
Test, Thrombin Time
90d
Cleared
Sep 25, 1992
HEMOLAB SILIMAT REAGENT
GFI
Osteotome, Manual
267d
Cleared
Sep 23, 1992
NEW STACHROM ANTIPLASMIN
GGP
Test, Qualitative And Quantitative Factor Deficiency
181d
Cleared
Sep 22, 1992
QBC HEMACAN HEMATOLOGY SYSTEM
GKL
Counter, Cell, Automated (particle Counter)
88d
Cleared
Sep 22, 1992
HEMOCHRON/FACTOR VI FIBRINOGEN ASSAY AND CONT PLAS
KQJ
System, Fibrinogen Determination
64d
Cleared
Sep 21, 1992
CLOTTRAC COAGULATION CONTROL
JBP
Activated Whole Blood Clotting Time
63d
Cleared
Sep 11, 1992
TECHNICON H*2
GKZ
Counter, Differential Cell
71d
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