Radioimmunoassay, Kanamycin

Device Code: 6157

Product Code(s): KJI

Device Classification Information

Device Type ID6157
Device NameRadioimmunoassay, Kanamycin
Regulation DescriptionKanamycin Test System.
Regulation Medical SpecialtyToxicology
Review PanelToxicology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number862.3520 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeKJI
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 ID6157
DeviceRadioimmunoassay, Kanamycin
Product CodeKJI
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionKanamycin Test System.
CFR Regulation Number862.3520 [🔎]
TPLC Last Update: 2019-04-02 21:18:03

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