Tanks, Developing, Tlc

Device Code: 5972

Product Code(s): DKK

Device Classification Information

Device Type ID5972
Device NameTanks, Developing, Tlc
Regulation DescriptionThin-layer 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 Number862.2270 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeDKK
GMP ExemptYes
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID5972
DeviceTanks, Developing, Tlc
Product CodeDKK
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionThin-layer Chromatography System For Clinical Use.
CFR Regulation Number862.2270 [🔎]
TPLC Last Update: 2019-04-02 21:15:27

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