Liquid Chromatography, Amphetamine

Device Code: 6104

Product Code(s): DNI

Device Classification Information

Device Type ID6104
Device NameLiquid Chromatography, Amphetamine
Regulation DescriptionAmphetamine Test System.
Regulation Medical SpecialtyToxicology
Review PanelToxicology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number862.3100 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeDNI
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 ID6104
DeviceLiquid Chromatography, Amphetamine
Product CodeDNI
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionAmphetamine Test System.
CFR Regulation Number862.3100 [🔎]
TPLC Last Update: 2019-04-02 21:17:20

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