Radioimmunoassay, Sisomicin

Device Code: 6281

Product Code(s): LBY

Device Classification Information

Device Type ID6281
Device NameRadioimmunoassay, Sisomicin
Review PanelToxicology
Premarket Review Office Of In Vitro Diagnostics And Radiological Health (OIR)
Submission Type510(k)
FDA Device ClassificationClass Unclassified Medical Device
Product CodeLBY
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID6281
DeviceRadioimmunoassay, Sisomicin
Product CodeLBY
TPLC Last Update: 2019-04-02 21:19:48

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.