Column, Adsorption, Low Density, Lipoprotein

Device Code: 2204

Product Code(s): LXW

Device Classification Information

Device Type ID2204
Device NameColumn, Adsorption, Low Density, Lipoprotein
Review PanelGastroenterology/Urology
Premarket Review Office Of Device Evaluation (ODE)
Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD)
Renal Devices Branch (RNDB)
Submission TypeContact ODE
FDA Device ClassificationClass 3 Medical Device
Product CodeLXW
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID2204
DeviceColumn, Adsorption, Low Density, Lipoprotein
Product CodeLXW
FDA Device ClassificationClass 3 Medical Device
TPLC Last Update: 2019-04-02 20:07:43

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