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
May 14, 2002
I-STAT PROTHROMBIN TIME TEST
GJS
Test, Time, Prothrombin
99d
Cleared
May 14, 2002
G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE
JPD
Hemoglobin A2 Quantitation
90d
Cleared
May 14, 2002
AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROL
GLK
Control, Hematocrit
78d
Cleared
May 14, 2002
HEMOSIL LOW ABNORMAL CONTROLLED (ASSAYED)
GGN
Plasma, Coagulation Control
46d
Cleared
May 14, 2002
HEMOSIL NORMAL CONTROL (ASSAYED)
GGN
Plasma, Coagulation Control
46d
Cleared
May 06, 2002
INRATIO
GJS
Test, Time, Prothrombin
63d
Cleared
Apr 24, 2002
POLYMEDCO HBA1C TEST
LCP
Assay, Glycosylated Hemoglobin
64d
Cleared
Apr 16, 2002
ACTICHROME HEPARIN (ANTI-FIIA)
KFF
Assay, Heparin
162d
Cleared
Apr 15, 2002
LYPHOCHEK HEMOSTASIS, MODELS 798, 799
GGC
Control, Plasma, Abnormal
28d
Cleared
Apr 12, 2002
HPC (HEMATOPOIETIC PROGENITOR CELL) PARAMETER ON THE IMI CHANNEL OF THE SYSMEX SE-9500 AND XE-2100, AUTOMATED HEMATOLOGY
GKZ
Counter, Differential Cell
57d
Cleared
Apr 04, 2002
CAL-CHEX CD PLUS
KRX
Calibrator For Cell Indices
51d
Cleared
Apr 02, 2002
IMMUNE CELL FUNCTION ASSAY
NID
Assay, Proliferation, In Vitro, T Lymphocyte
193d
Cleared
Mar 28, 2002
HEMOCHRON JR. SIGNATURE +
JPA
System, Multipurpose For In Vitro Coagulation Studies
16d
Cleared
Mar 15, 2002
AUTODIMER ASSAY MODEL # 1431
DAP
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
211d
Cleared
Mar 13, 2002
AUTOMARQER
POV
Semen Analysis Device
204d
Cleared
Mar 13, 2002
IMUBIND TPA ELISA, MODEL 860
GGP
Test, Qualitative And Quantitative Factor Deficiency
142d
Cleared
Mar 08, 2002
ACTICHROME HEPARIN (ANTI-FXA), MODEL 832
KFF
Assay, Heparin
154d
Cleared
Mar 07, 2002
IMUBIND PLASMA PAI-1 ELISA,MODEL 822
GGP
Test, Qualitative And Quantitative Factor Deficiency
167d
Cleared
Mar 05, 2002
ASTOFLO
BSB
Warmer, Blood, Non-electromagnetic Radiation
56d
Cleared
Feb 28, 2002
ABX MICROS 60 HEMATOLOGY ANALYZER
GKX
Instrument, Automated Platelet Counting
69d
Cleared
Feb 15, 2002
PACIFIC HEMOSTASIS REFERENCE EMULSION
JIX
Calibrator, Multi-analyte Mixture
123d
Cleared
Feb 15, 2002
A1CNOW FOR RX HOME USE
LCP
Assay, Glycosylated Hemoglobin
23d
Cleared
Feb 15, 2002
A1CNOW FOR PROFESSIONAL USE
LCP
Assay, Glycosylated Hemoglobin
23d
Cleared
Feb 11, 2002
STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090
KHG
Whole Blood Hemoglobin Determination
26d
Cleared
Feb 08, 2002
CARESIDE APTT
GFO
Activated Partial Thromboplastin
64d
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