Lectins And Protectins

Device Code: 2394

Product Code(s): KSI

Device Classification Information

Device Type ID2394
Device NameLectins And Protectins
Regulation DescriptionLectins And Protectins.
Regulation Medical SpecialtyHematology
Review PanelHematology
Premarket Review Center For Biologics Evaluation & Research (CBER)
Submission Type510(K) Exempt
CFR Regulation Number864.9550 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeKSI
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2394
DeviceLectins And Protectins
Product CodeKSI
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionLectins And Protectins.
CFR Regulation Number864.9550 [🔎]
TPLC Last Update: 2019-04-02 20:11:05

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