Radioimmunoassay, Amikacin

Device Code: 6162

Product Code(s): KLQ

Device Classification Information

Device Type ID6162
Device NameRadioimmunoassay, Amikacin
Regulation DescriptionAmikacin Test System.
Regulation Medical SpecialtyToxicology
Review PanelToxicology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
CFR Regulation Number862.3035 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeKLQ
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 ID6162
DeviceRadioimmunoassay, Amikacin
Product CodeKLQ
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionAmikacin Test System.
CFR Regulation Number862.3035 [🔎]
TPLC Last Update: 2019-04-02 21:18:07

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