Liquid Chromatography, Morphine

Device Code: 6143

Product Code(s): DPK

Device Classification Information

Device Type ID6143
Device NameLiquid Chromatography, Morphine
Regulation DescriptionMorphine Test System.
Regulation Medical SpecialtyToxicology
Review PanelToxicology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number862.3640 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeDPK
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Program

Recognized Standards

Total Product Life Cycle

Device Type ID6143
DeviceLiquid Chromatography, Morphine
Product CodeDPK
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionMorphine Test System.
CFR Regulation Number862.3640 [🔎]
TPLC Last Update: 2019-04-02 21:17:52

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