Thin Layer Chromatography, Amphetamine

Device Code: 6033

Product Code(s): DIT

Device Classification Information

Device Type ID6033
Device NameThin Layer 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 CodeDIT
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 ID6033
DeviceThin Layer Chromatography, Amphetamine
Product CodeDIT
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionAmphetamine Test System.
CFR Regulation Number862.3100 [🔎]
TPLC Last Update: 2019-04-02 21:16:19

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