Thin Layer Chromatography, Salicylate

Device Code: 6041

Product Code(s): DJE

Device Classification Information

Device Type ID6041
Device NameThin Layer 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 CodeDJE
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 ID6041
DeviceThin Layer Chromatography, Salicylate
Product CodeDJE
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionSalicylate Test System.
CFR Regulation Number862.3830 [🔎]
TPLC Last Update: 2019-04-02 21:16:25

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