LCE — Radioimmunoassay, Netilmicin (I-125) Class II

FDA Device Classification

Classification Details

Product Code
LCE
Device Class
Class II
Regulation Number
862.3450
Submission Type
Review Panel
TX
Medical Specialty
Clinical Toxicology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K833715syvaEMIT NETILMICIN ASSAYDecember 27, 1983
K832088miles laboratoriesAMES TDA NETILMICIN TEST & SERUMOctober 28, 1983
K822941american diagnosticNETILMICIN FLUORESCENT IMMUNOASSAYOctober 26, 1982
K821698abbott laboratoriesTDX NETILMICINJune 22, 1982
K821399bd becton dickinson vacutainer systems preanalyticMACRO-VUE CARD TEST, NETILMICINMay 28, 1982
K820324syvaEMIT AND NETILMICIN ASSAYFebruary 23, 1982