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
2619 Hematology devices
Cleared
Sep 30, 1988
REP GLYCO SYSTEM
LCP
Assay, Glycosylated Hemoglobin
150d
Cleared
Sep 30, 1988
HELENA COLOCARE
KHE
Reagent, Occult Blood
86d
Cleared
Sep 13, 1988
VISION(R) PROTHROMBIN TIME
GJS
Test, Time, Prothrombin
29d
Cleared
Sep 02, 1988
STACHROM ANTIPLASMIN TEST KIT
GGP
Test, Qualitative And Quantitative Factor Deficiency
70d
Cleared
Sep 02, 1988
STACHROM ANTIPLASMIN CONTROL
GGP
Test, Qualitative And Quantitative Factor Deficiency
70d
Cleared
Aug 30, 1988
HEMOCHRON CONTROL PLASMA NORMAL/ABNORMAL LEV. I/II
GGN
Plasma, Coagulation Control
75d
Cleared
Aug 30, 1988
HEMOCHRON CONTROL ACT TEST TUBE NORMAL/ABNOR. I/II
GGN
Plasma, Coagulation Control
75d
Cleared
Aug 25, 1988
UNIFAST ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST
GFO
Activated Partial Thromboplastin
80d
Cleared
Aug 25, 1988
SYSMEX K-1000 18 PARAMETER, AUTO. HEMA ANALYZER
GKZ
Counter, Differential Cell
78d
Cleared
Aug 25, 1988
OWREN'S VERONAL BUFFER
JPA
System, Multipurpose For In Vitro Coagulation Studies
9d
Cleared
Aug 17, 1988
PLATELIN(R) EXCEL L
GIT
Reagent & Control, Partial Thromboplastin Time
97d
Cleared
Aug 12, 1988
BINAX EQUATE GLYCOHEMOGLOBIN
LCP
Assay, Glycosylated Hemoglobin
268d
Cleared
Aug 09, 1988
FIBRINOGENTEST-O
GIS
Test, Fibrinogen
112d
Cleared
Aug 01, 1988
BIO-RAD HEMOGLOBIN DETECTOR
LCP
Assay, Glycosylated Hemoglobin
77d
Cleared
Aug 01, 1988
DETERMIN HEMOGLOBIN ALC/HI PERF LIQ CHROMATOGRAPHY
LCP
Assay, Glycosylated Hemoglobin
67d
Cleared
Jul 25, 1988
HYCEL QUICK-LYSING HEMOGLOBIN REAGENT
GIF
Diluent, Blood Cell
39d
Cleared
Jul 18, 1988
ACCUFIBRIN(TM) BLOOD COLLECTION SYSTEM AF100
GIM
Tubes, Vacuum Sample, With Anticoagulant
31d
Cleared
Jul 18, 1988
SYSMEX DD-100 WHOLE BLOOD DILUTION SYSTEM
GKH
Apparatus, Automated Blood Cell Diluting
12d
Cleared
Jul 12, 1988
SYSMEX QUICKLYSER-II (QLS-200A)
GIF
Diluent, Blood Cell
42d
Cleared
Jul 08, 1988
IMMUNOCCULT EIA TEST KIT
KHE
Reagent, Occult Blood
473d
Cleared
Jul 01, 1988
PAT PLATELET AGGREGATION TEST
JBX
Aggregrometer, Platelet
63d
Cleared
Jul 01, 1988
SIMPLASTIN EXCEL S
GJS
Test, Time, Prothrombin
36d
Cleared
Jun 27, 1988
ACL SYSTEMS 100, 200, 300 AND 300+ COAGULATION SYS
JPA
System, Multipurpose For In Vitro Coagulation Studies
88d
Cleared
May 23, 1988
HEMOCCULT SENSITIVE TEST
KHE
Reagent, Occult Blood
108d
Cleared
May 18, 1988
COAG-A-MATE(R) XM
GKP
Instrument, Coagulation, Automated
54d
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