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 25, 1995
MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD2, CLONE MT910 FITC-CONJUGATED, (ANTI-CD2,FITC, MT910)
GKZ
Counter, Differential Cell
65d
Cleared
Jan 24, 1995
PROTEIN C REAGENT, COAGULOMETRIC
GGP
Test, Qualitative And Quantitative Factor Deficiency
875d
Cleared
Jan 20, 1995
QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS
JCM
Control, Hemoglobin, Abnormal
259d
Cleared
Jan 20, 1995
QUIK-SEP QUANTITATIVE HEMOGLOBIN S ASSAY
GIQ
Hemoglobin S
255d
Cleared
Jan 17, 1995
BIOMERIEUX HEMOLAB COFAC VII
GJT
Plasma, Coagulation Factor Deficient
405d
Cleared
Jan 17, 1995
BIOMERIEUX HEMOLAB COFAC X
GJT
Plasma, Coagulation Factor Deficient
405d
Cleared
Jan 11, 1995
RISTOCETIN COFACTOR ASSAY KIT
GGP
Test, Qualitative And Quantitative Factor Deficiency
65d
Cleared
Dec 22, 1994
HEMOLAB
GKP
Instrument, Coagulation, Automated
608d
Cleared
Dec 22, 1994
HEMOLAB PROTEIN C CHROMOGENIC ASSAY
GGP
Test, Qualitative And Quantitative Factor Deficiency
479d
Cleared
Dec 15, 1994
SCS-1000 (SYSMEX CALIBRATOR SYSTEM)
KSA
Calibrator For Red-cell And White-cell Counting
161d
Cleared
Dec 14, 1994
TECHNICON H* 3 RTC SYSTEM (IN-VITRO DIAGNOSTIC SYSTEM)
GKZ
Counter, Differential Cell
275d
Cleared
Dec 12, 1994
RETIC CONTROL-M HEMATOLOGY CONTROL/MULTIPLE
JPK
Mixture, Hematology Quality Control
153d
Cleared
Dec 12, 1994
RETIC CONTROL-H HEMATOLOGY CONTROL/MULTIPLE
JPK
Mixture, Hematology Quality Control
153d
Cleared
Dec 08, 1994
COULTER FLOW SET
JPK
Mixture, Hematology Quality Control
73d
Cleared
Dec 02, 1994
APTT-ES
GFO
Activated Partial Thromboplastin
402d
Cleared
Nov 22, 1994
DADE(R) THROMBIN-ANTITHROMBIN (TAT) COMPLEX ELISA
DDQ
Antigen, Antiserum, Control, Antithrombin Iii
385d
Cleared
Nov 22, 1994
DADE INNOVIN II
GJS
Test, Time, Prothrombin
357d
Cleared
Nov 21, 1994
SPECIALTY ASSAYED CONTROL-2 CAT. NO. 5302
GGC
Control, Plasma, Abnormal
217d
Cleared
Nov 21, 1994
MONOCLONAL MOUSE ANTI-HUMAN B-CELL
GKZ
Counter, Differential Cell
137d
Cleared
Nov 21, 1994
MONOCLONAL MOUSE ANTI-HUMAN T-CELL, CD8, RPE-CONJUGATED, CLONE DK25
GKZ
Counter, Differential Cell
82d
Cleared
Nov 10, 1994
MONOCLONAL MOUSE ANTI-HUMAN T-CELL
GKZ
Counter, Differential Cell
148d
Cleared
Oct 31, 1994
AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328
JCM
Control, Hemoglobin, Abnormal
495d
Cleared
Oct 27, 1994
GENESIS 1, AUTOMATED CELL COUNTER, MODIFICATION
GKZ
Counter, Differential Cell
723d
Cleared
Oct 18, 1994
HEMOCHRON VERIGY SYSTEM/FACTOR VI QUALIFY SYSTEM
JPA
System, Multipurpose For In Vitro Coagulation Studies
231d
Cleared
Oct 13, 1994
AGGRO/LINK VW COFACTOR SOFTWARE
JOZ
System, Automated Platelet Aggregation
233d
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