Thin Layer Chromatography, Methamphetamine

Device Code: 6039

Product Code(s): DJC

Device Classification Information

Device Type ID6039
Device NameThin Layer Chromatography, Methamphetamine
Regulation DescriptionMethamphetamine Test System.
Regulation Medical SpecialtyToxicology
Review PanelToxicology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number862.3610 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeDJC
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 ID6039
DeviceThin Layer Chromatography, Methamphetamine
Product CodeDJC
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionMethamphetamine Test System.
CFR Regulation Number862.3610 [🔎]
Device Problems
Patient-Device Incompatibility
2
Total Device Problems 2
TPLC Last Update: 2019-04-02 21:16:24

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