High Pressure Liquid Chromatography, Benzodiazepine

Device Code: 6173

Product Code(s): LAA

Device Classification Information

Device Type ID6173
Device NameHigh Pressure Liquid Chromatography, Benzodiazepine
Regulation DescriptionBenzodiazepine Test System.
Regulation Medical SpecialtyToxicology
Review PanelToxicology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number862.3170 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeLAA
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID6173
DeviceHigh Pressure Liquid Chromatography, Benzodiazepine
Product CodeLAA
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionBenzodiazepine Test System.
CFR Regulation Number862.3170 [🔎]
TPLC Last Update: 2019-04-02 21:18:17

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.