Amikacin Serum Assay

Device Code: 6161

Product Code(s): KLP

Device Classification Information

Device Type ID6161
Device NameAmikacin Serum Assay
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 CodeKLP
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 ID6161
DeviceAmikacin Serum Assay
Product CodeKLP
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionAmikacin Test System.
CFR Regulation Number862.3035 [🔎]
TPLC Last Update: 2019-04-02 21:18:06

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