Thin Layer Chromatography, Phenobarbital

Device Code: 6035

Product Code(s): DIX

Device Classification Information

Device Type ID6035
Device NameThin Layer Chromatography, Phenobarbital
Regulation DescriptionPhenobarbital Test System.
Regulation Medical SpecialtyToxicology
Review PanelToxicology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number862.3660 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeDIX
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 ID6035
DeviceThin Layer Chromatography, Phenobarbital
Product CodeDIX
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionPhenobarbital Test System.
CFR Regulation Number862.3660 [🔎]
TPLC Last Update: 2019-04-02 21:16:20

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