Thin Layer Chromatography, Morphine

Device Code: 6106

Product Code(s): DNK

Device Classification Information

Device Type ID6106
Device NameThin Layer 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 CodeDNK
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 ID6106
DeviceThin Layer Chromatography, Morphine
Product CodeDNK
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionMorphine Test System.
CFR Regulation Number862.3640 [🔎]
TPLC Last Update: 2019-04-02 21:17:22

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