Apparatus, High Pressure Liquid Chromatography

Device Code: 5991

Product Code(s): KIE

Device Classification Information

Device Type ID5991
Device NameApparatus, High Pressure Liquid Chromatography
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 CodeKIE
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5991
DeviceApparatus, High Pressure Liquid Chromatography
Product CodeKIE
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionHigh Pressure Liquid Chromatography System For Clinical Use.
CFR Regulation Number862.2260 [🔎]
Device Problems
Incorrect Or Inadequate Test Results
1
Total Device Problems 1
TPLC Last Update: 2019-04-02 21:15:43

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