Liquid Chromatography, Adsorbent

Device Code: 5982

Product Code(s): DMZ

Device Classification Information

Device Type ID5982
Device NameLiquid Chromatography, Adsorbent
Regulation DescriptionHigh Pressure 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 Number862.2260 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeDMZ
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5982
DeviceLiquid Chromatography, Adsorbent
Product CodeDMZ
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionHigh Pressure Liquid Chromatography System For Clinical Use.
CFR Regulation Number862.2260 [🔎]
TPLC Last Update: 2019-04-02 21:15:35

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