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
2616 Hematology devices
Cleared
May 10, 2006
ACTALYKE QC KIT, MODELS AQC-HP AND AQC-LP
JPA
System, Multipurpose For In Vitro Coagulation Studies
27d
Cleared
May 04, 2006
STA-CEPHASCREEN KIT
GFO
Activated Partial Thromboplastin
181d
Cleared
May 04, 2006
INSURE II
KHE
Reagent, Occult Blood
29d
Cleared
May 02, 2006
HEMOSIL PT-FIBRINOGEN HS PLUS
GJS
Test, Time, Prothrombin
27d
Cleared
Apr 14, 2006
GUAVA EZCD4 SYSTEM
GKZ
Counter, Differential Cell
120d
Cleared
Apr 13, 2006
HEMOSIL SYNTHASIL
GFO
Activated Partial Thromboplastin
29d
Cleared
Mar 28, 2006
COULTER 5C CELL CONTROL
JPK
Mixture, Hematology Quality Control
34d
Cleared
Mar 16, 2006
IMMOCARE
KHE
Reagent, Occult Blood
176d
Cleared
Mar 08, 2006
RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367
GKA
Abnormal Hemoglobin Quantitation
355d
Cleared
Feb 21, 2006
ACL ELITE
JPA
System, Multipurpose For In Vitro Coagulation Studies
29d
Cleared
Feb 09, 2006
NRBC-CHEX FOR LH
GJR
Control, Red-cell
29d
Cleared
Jan 24, 2006
IKONISCOPE FASTFISH AMNIO IMAGING SYSTEM
JOY
Device, Automated Cell-locating
127d
Cleared
Jan 20, 2006
VISULIZE FACTOR VIII ANTIGEN KIT, MODEL FVIII-AG
GGP
Test, Qualitative And Quantitative Factor Deficiency
107d
Cleared
Jan 20, 2006
PF4 ENHANCED SOLID PHASE ELISA
LCO
Platelet Factor 4 Radioimmunoassay
30d
Cleared
Jan 13, 2006
CELL-CHEX AUTO
JPK
Mixture, Hematology Quality Control
42d
Cleared
Jan 13, 2006
HEMOSIL PROS
GGP
Test, Qualitative And Quantitative Factor Deficiency
28d
Cleared
Jan 04, 2006
HEPARIN/PLATELET FACTOR 4 ANTIBODY SERUM PANEL
GGN
Plasma, Coagulation Control
98d
Cleared
Jan 04, 2006
SMARTPREP2 CENTRIFUGE SYSTEM
JQC
Centrifuges (micro, Ultra, Refrigerated) For Clinical Use
78d
Cleared
Dec 29, 2005
ABX MICROS CRP 200, OPTION IM
GKZ
Counter, Differential Cell
31d
Cleared
Dec 27, 2005
BIOPHEN PROTEIN C5, C2.5, MODELS 221205, 221202
GGP
Test, Qualitative And Quantitative Factor Deficiency
316d
Cleared
Dec 23, 2005
COAG-A-MATE MTX III
JPA
System, Multipurpose For In Vitro Coagulation Studies
245d
Cleared
Dec 23, 2005
BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR
GGN
Plasma, Coagulation Control
203d
Cleared
Dec 22, 2005
CHEMPAQ XBC ANALYZER
GKZ
Counter, Differential Cell
274d
Cleared
Dec 12, 2005
T-TEK
GJA
Test, Thrombin Time
256d
Cleared
Dec 07, 2005
MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM
GKL
Counter, Cell, Automated (particle Counter)
167d
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