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
Jul 08, 1988
IMMUNOCCULT EIA TEST KIT
KHE
Reagent, Occult Blood
473d
Cleared
Jul 08, 1988
HEMAGEL(TM) TEST FOR FECAL OCCULT BLOOD
KHE
Reagent, Occult Blood
63d
Cleared
Jul 01, 1988
SPECTROLYSE/FIBRIN
GGP
Test, Qualitative And Quantitative Factor Deficiency
112d
Cleared
Jul 01, 1988
PAT PLATELET AGGREGATION TEST
JBX
Aggregrometer, Platelet
63d
Cleared
Jul 01, 1988
HEMOGLOBIN SCREENING DEVICE
KSL
Solution, Copper Sulfate For Specific Gravity Determinations
51d
Cleared
Jul 01, 1988
MINIFUGE, MODEL 70
GPG
Antigen, Latex Agglutination, Trichinella Spiralis
39d
Cleared
Jul 01, 1988
SIMPLASTIN EXCEL S
GJS
Test, Time, Prothrombin
36d
Cleared
Jun 29, 1988
ASTROSCAN 2100 MICROTITER PLATE READER
JJQ
Colorimeter, Photometer, Spectrophotometer For Clinical Use
83d
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
Cleared
May 13, 1988
REVISED IMMUDIA HEM-SP
KHE
Reagent, Occult Blood
206d
Cleared
May 13, 1988
MICROHEMATOCRIT TUBES, HEPARIN & MICROHEMA TUBE,PL
GHY
Hematocrit, Tube, Rack, Sealer, Holder
53d
Cleared
May 06, 1988
TITAN GEL-PC GLYCO-HEME(TM) SYSTEM
LCP
Assay, Glycosylated Hemoglobin
74d
Cleared
May 06, 1988
CLP NORMAL COAGULATION CONTROL
GIZ
Plasma, Control, Normal
74d
Cleared
May 06, 1988
NATELSON TUBES, HEPARIN AND PLAIN
GIO
Tube, Collection, Capillary Blood
46d
Cleared
May 06, 1988
CARAWAY TUBES, HEPARIN AND PLAIN
GIO
Tube, Collection, Capillary Blood
43d
Cleared
May 06, 1988
CLP ABNORMAL COAGULATION CONTROL
GGC
Control, Plasma, Abnormal
25d
Cleared
May 02, 1988
MINOS AUTOMATIC CELL COUNTER
GKZ
Counter, Differential Cell
76d
Cleared
May 02, 1988
TECH-CAL(TM)/MULTIPLE
KSA
Calibrator For Red-cell And White-cell Counting
45d
Cleared
May 02, 1988
VERIFY(R) REFERENCE PLASMA
GGN
Plasma, Coagulation Control
33d
Cleared
Apr 27, 1988
ENZYGNOST(R) TAT REAGENTS
JBQ
Antithrombin Iii Quantitation
65d
Cleared
Apr 27, 1988
LX-100 SLIDE STAINER
KPA
Slide Stainer, Automated
63d
Cleared
Apr 21, 1988
FOR THE DETER. OF HEMOGLOBIN IN PLASMA #527
KHG
Whole Blood Hemoglobin Determination
107d
Cleared
Apr 21, 1988
HBF DILUENT
KQI
Assay, Fetal Hemoglobin
64d
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