High Pressure Liquid Chromatography, Methamphetamine

Device Code: 6179

Product Code(s): LAG

Device Classification Information

Device Type ID6179
Device NameHigh Pressure Liquid 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 CodeLAG
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 ID6179
DeviceHigh Pressure Liquid Chromatography, Methamphetamine
Product CodeLAG
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionMethamphetamine Test System.
CFR Regulation Number862.3610 [🔎]
TPLC Last Update: 2019-04-02 21:18:24

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