Gas Chromatography, Salicylate

Device Code: 6026

Product Code(s): DIM

Device Classification Information

Device Type ID6026
Device NameGas Chromatography, Salicylate
Regulation DescriptionSalicylate Test System.
Regulation Medical SpecialtyToxicology
Review PanelToxicology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number862.3830 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeDIM
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 ID6026
DeviceGas Chromatography, Salicylate
Product CodeDIM
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionSalicylate Test System.
CFR Regulation Number862.3830 [🔎]
TPLC Last Update: 2019-04-02 21:16:14

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