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
Oct 19, 2012
XN CAL
KRX
Calibrator For Cell Indices
221d
Cleared
Aug 02, 2012
ABACUS 3CP
GKZ
Counter, Differential Cell
427d
Cleared
Jul 31, 2012
VIDAS D-DIMER EXCLUSION II (DEX2)
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
307d
Cleared
Jul 27, 2012
MULTIPLATE 5.0 AGGREGOMETER
JOZ
System, Automated Platelet Aggregation
602d
Cleared
May 25, 2012
CAPILLARYS HEMOGLOBIN, CAPILLARYS FLEX PIERCING SYSTEM
GKA
Abnormal Hemoglobin Quantitation
267d
Cleared
May 24, 2012
SEBIA CAPILLARYS HEMOGLOBIN(E) WITH CAPILLARYS 2
GKA
Abnormal Hemoglobin Quantitation
269d
Cleared
May 01, 2012
INRATIO2 PI/NR MONITORING SYSTEM
GJS
Test, Time, Prothrombin
462d
Cleared
Mar 27, 2012
ABACUS 5
GKZ
Counter, Differential Cell
188d
Cleared
Jan 04, 2012
HEMOSIL LA POSITIVE CONTROL & HEMOSIL LA NEGATIVE CONTROL
GGN
Plasma, Coagulation Control
65d
Cleared
Dec 22, 2011
CELL-DYN EMERALD 22 SYSTEM
GKZ
Counter, Differential Cell
315d
Cleared
Dec 22, 2011
CELL-DYN 22 PLUS CALIBRATOR
KRX
Calibrator For Cell Indices
237d
Cleared
Dec 22, 2011
CELL-DYN 22 PLUS CONTROL
GLQ
Mixture, Control, White-cell And Red-cell Indices
237d
Cleared
Dec 19, 2011
NOFACT VIII
GJT
Plasma, Coagulation Factor Deficient
446d
Cleared
Dec 19, 2011
NOFACT IX
GJT
Plasma, Coagulation Factor Deficient
444d
Cleared
Nov 23, 2011
ADVIA 2120 WITH AUTOSLIDE SYSTEM, AND ADVIA 2120I
GKZ
Counter, Differential Cell
435d
Cleared
Nov 16, 2011
THE BELMONT BUDDY LITE FLUID WARMER
BSB
Warmer, Blood, Non-electromagnetic Radiation
65d
Cleared
Oct 26, 2011
STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH
KFF
Assay, Heparin
120d
Cleared
Oct 20, 2011
VISUCON-F FROZEN COAG SCREEN N, VISUCON-F FROZEN COAG SCREEN ABN
GGN
Plasma, Coagulation Control
247d
Cleared
Sep 16, 2011
CELLAVISION DM1200 WITH THE BODY FLUID APPLICTION
JOY
Device, Automated Cell-locating
357d
Cleared
Sep 14, 2011
FOB ONE STEP RAPID TEST
KHE
Reagent, Occult Blood
224d
Cleared
Aug 24, 2011
HEMOSIL DRVVT SCREEN & HEMOSIL DRVVT CONFIRM
GIR
Reagent, Russel Viper Venom
231d
Cleared
Aug 10, 2011
EX-TEM. FIB-TEM, AND AP-TEM FOR ROTEM DELTA THROMBOELASTOMETRY SYSTEM
JPA
System, Multipurpose For In Vitro Coagulation Studies
433d
Cleared
Jul 08, 2011
HEMOSIL FACTOR VIII DEFICIENT PLASMA
GJT
Plasma, Coagulation Factor Deficient
163d
Cleared
Jun 23, 2011
AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5
GGN
Plasma, Coagulation Control
468d
Cleared
Jun 08, 2011
HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)
JOX
Analyzer, Heparin, Automated
27d
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