Columns, Glc

Device Code: 5966

Product Code(s): DII

Device Classification Information

Device Type ID5966
Device NameColumns, Glc
Regulation DescriptionGas Liquid Chromatography System For Clinical Use.
Regulation Medical SpecialtyClinical Chemistry
Review PanelToxicology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(K) Exempt
CFR Regulation Number862.2250 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeDII
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5966
DeviceColumns, Glc
Product CodeDII
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionGas Liquid Chromatography System For Clinical Use.
CFR Regulation Number862.2250 [🔎]
TPLC Last Update: 2019-04-02 21:15:22

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