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
Jan 16, 2003
MODIFICATION TO STANDARD HUMAN PLASMA
JPA
System, Multipurpose For In Vitro Coagulation Studies
118d
Cleared
Jan 14, 2003
HEMOSIL FACTOR V DEFICIENT PLASMA
GJT
Plasma, Coagulation Factor Deficient
57d
Cleared
Jan 14, 2003
CDS 3-PD HEMATOLOGY CONTROLS
JPK
Mixture, Hematology Quality Control
27d
Cleared
Jan 03, 2003
PENTRA 80
GKZ
Counter, Differential Cell
30d
Cleared
Dec 30, 2002
SICKLE-CHEX SOLUBILITY KIT
GHM
Test, Sickle Cell
61d
Cleared
Dec 13, 2002
A1CNOW FOR HOME USE
LCP
Assay, Glycosylated Hemoglobin
126d
Cleared
Dec 09, 2002
FISHER DIAGNOSTICS THROMBOSCREEN 1000
GKP
Instrument, Coagulation, Automated
63d
Cleared
Nov 27, 2002
STRATUS CS D-DIMER CALPAK CALIBRATOR, MODEL CDDMR-C
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
82d
Cleared
Nov 01, 2002
VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT
GFO
Activated Partial Thromboplastin
134d
Cleared
Nov 01, 2002
CONTROL PLASMA N
GIZ
Plasma, Control, Normal
29d
Cleared
Nov 01, 2002
CONTROL PLASMA P
GGC
Control, Plasma, Abnormal
29d
Cleared
Oct 25, 2002
PT-S TEST STRIPS FOR THE COAGUCHEK SYSTEM, MODEL# 2032422
GJS
Test, Time, Prothrombin
193d
Cleared
Oct 25, 2002
FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON
KQG
Instrument, Coagulation
130d
Cleared
Oct 24, 2002
PT S TEST STRIPS AND CONTROLS FOR THE COAGUCHEK S SYSTEM, MODELS 2032422 AND 3271404
GJS
Test, Time, Prothrombin
224d
Cleared
Oct 24, 2002
INRATIO SELF-TEST
GJS
Test, Time, Prothrombin
135d
Cleared
Oct 15, 2002
ADVIA 120 HEMATOLOGY SYSTEM COMPLETE BLOOD COUNT (CBC) METHOD
GKZ
Counter, Differential Cell
64d
Cleared
Oct 03, 2002
VIDAS D-DIMER NEW (DD2) ASSAY MODEL#30 442
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
204d
Cleared
Sep 30, 2002
CELLPREP SAMPLE PREPARATION SYSTEM, MODEL 9518
GKH
Apparatus, Automated Blood Cell Diluting
62d
Cleared
Sep 30, 2002
HARMONY INR MONITORING SYSTEM
GJS
Test, Time, Prothrombin
26d
Cleared
Sep 24, 2002
LIFEGUARD
KHE
Reagent, Occult Blood
35d
Cleared
Sep 24, 2002
ADVIA TESTPOINT CSF CONTROL
JPK
Mixture, Hematology Quality Control
18d
Cleared
Sep 20, 2002
SQA V, SPERM QUALITY ANALYZER
POV
Semen Analysis Device
115d
Cleared
Sep 11, 2002
ADVIA 120 HEMATOLOGY SYSTEM, CEREBROSPINAL FLUID METHOD
GKL
Counter, Cell, Automated (particle Counter)
55d
Cleared
Sep 11, 2002
IQ PRODUCTS TRIPLE-COLOR FLOW CYTOMETRY REAGENTS, IQ PRODUCTS CD45-FITC/CD4-PE/CD3-CYQ, IQ PRODUCTS CD45-FITC/CD8-PE/CDQ
GKZ
Counter, Differential Cell
42d
Cleared
Aug 30, 2002
AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED
JPA
System, Multipurpose For In Vitro Coagulation Studies
141d
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