Gas Chromatography, Methadone

Device Code: 6085

Product Code(s): DMB

Device Classification Information

Device Type ID6085
Device NameGas Chromatography, Methadone
Regulation DescriptionMethadone Test System.
Regulation Medical SpecialtyToxicology
Review PanelToxicology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number862.3620 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeDMB
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 ID6085
DeviceGas Chromatography, Methadone
Product CodeDMB
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionMethadone Test System.
CFR Regulation Number862.3620 [🔎]
TPLC Last Update: 2019-04-02 21:17:04

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