High Pressure Liquid Chromatography, Codeine

Device Code: 6177

Product Code(s): LAE

Device Classification Information

Device Type ID6177
Device NameHigh Pressure Liquid Chromatography, Codeine
Regulation DescriptionCodeine Test System.
Regulation Medical SpecialtyToxicology
Review PanelToxicology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number862.3270 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeLAE
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 ID6177
DeviceHigh Pressure Liquid Chromatography, Codeine
Product CodeLAE
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionCodeine Test System.
CFR Regulation Number862.3270 [🔎]
TPLC Last Update: 2019-04-02 21:18:21

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