Part 864 Subpart F—Automated and Semi-Automated Hematology Devices

FDA submissions for Part 864 Subpart F—Automated and Semi-Automated Hematology Devices in the Hematology (HE) review panel, including product codes and regulations.

Section range: §§ 864.5200–864.5950

CFR Part: 864

Product Codes

Product CodeDevice NameRegulationClassDevices
GKLCounter, Cell, Automated (Particle Counter)864.52002130
GKXInstrument, Automated Platelet Counting864.520022
LKMCounter, Urine Particle864.5200215
GKZCounter, Differential Cell864.52202379
LIZAssay, T Lymphocyte Surface Marker864.522027
LJDAssay, B Lymphocyte Marker864.522021
MAMDna-Probe, B And T Lymphocyte864.522022
NIDAssay, Proliferation, In Vitro, T Lymphocyte864.522022
OYEFlow Cytometric Reagents And Accessories.864.522028
PDXFlow Cytometry Calibrator864.522020
PMGAutomated Multicolor Fluorescent Imaging Cytometric Analysis System864.522021
POVSemen Analysis Device864.5220228
GKHApparatus, Automated Blood Cell Diluting864.5240114
JOYDevice, Automated Cell-Locating864.5260235
LNJAnalyzer, Chromosome, Automated864.5260211
SALDevice, Automated Cell Locating, Bone Marrow864.526121
JBWRed-Cell Indices, Measured864.530020
JPJRed-Cell Indices, Calculated864.530023
KQHRed-Cell Indices864.530021
GHKCentrifuge, Microsedimentation864.535010
GIEFibrometer864.540022
GKNTimer, Clot, Automated864.540023
GKPInstrument, Coagulation, Automated864.5400249
JBTTimer, Coagulation864.540020
KQGInstrument, Coagulation864.5400214
GGCControl, Plasma, Abnormal864.5425240
GGNPlasma, Coagulation Control864.5425299
GIZPlasma, Control, Normal864.5425220
JPASystem, Multipurpose For In Vitro Coagulation Studies864.54252180
LGPAssay, Alpha-2-Antiplasmin864.542525
LLGKit, Igg, Platelet Associated864.542522
QFRCoagulation System For The Measurement Of Whole Blood Viscoelastic Properties864.543028
GKFInstrument, Hematocrit, Automated864.5600215
GKRSystem, Hemoglobin, Automated864.5620239
JOXAnalyzer, Heparin, Automated864.5680215
GHRReagent, Platelet Aggregation864.5700211
JOZSystem, Automated Platelet Aggregation864.5700238
OBW11-Dehydro Thromboxane B2 Kit, Urinary864.570021
GKBDevice, Automated Sedimentation Rate864.580012
GKJSpinner, Slide, Automated864.585016
JWODevice, Blood Volume Measuring864.595022
Innolitics

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