Instrument, Coagulation

Device Code: 2380

Product Code(s): KQG

Device Classification Information

Device Type ID2380
Device NameInstrument, Coagulation
Regulation DescriptionCoagulation Instrument.
Regulation Medical SpecialtyHematology
Review PanelHematology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number864.5400 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeKQG
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2380
DeviceInstrument, Coagulation
Product CodeKQG
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionCoagulation Instrument.
CFR Regulation Number864.5400 [🔎]
TPLC Last Update: 2019-04-02 20:10:48

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