Fluorometry, Morphine

Device Code: 6046

Product Code(s): DJJ

Device Classification Information

Device Type ID6046
Device NameFluorometry, 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 CodeDJJ
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 ID6046
DeviceFluorometry, Morphine
Product CodeDJJ
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionMorphine Test System.
CFR Regulation Number862.3640 [🔎]
TPLC Last Update: 2019-04-02 21:16:29

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