Radioimmunoassay, Netilmicin (i-125)

Device Code: 6282

Product Code(s): LCE

Device Classification Information

Device Type ID6282
Device NameRadioimmunoassay, Netilmicin (i-125)
Review PanelToxicology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
FDA Device ClassificationClass Unclassified Medical Device
Product CodeLCE
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID6282
DeviceRadioimmunoassay, Netilmicin (i-125)
Product CodeLCE
TPLC Last Update: 2019-04-02 21:19:49

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