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DPB — Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Charcoal Sep. Class II

FDA Device Classification

Classification Details

Product Code
DPB
Device Class
Class II
Regulation Number
862.3320
Submission Type
Review Panel
TX
Medical Specialty
Clinical Toxicology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K853021miles laboratoriesOPTIMATE DIGOXIN TESTAugust 7, 1985
K823014pcl-riaDIGOXIN KITNovember 1, 1982
K821811cambridge medical technology125I DIGOXIN RADIOIMMUNOASSAY KITJuly 2, 1982
K820274american diagnosticDIGOXIN RADIOIMMUNOASSAYFebruary 23, 1982
K792153radioimmunoassayDIGOXIN RADIOIMMUNOASSAY SYSTEMNovember 13, 1979
K790602endocrine-metabolic centerRIA, DIGNXIN-125-IJuly 30, 1979
K790540ventrex laboratoriesRIA TEST KIT, CENTRIA DIGOXINApril 23, 1979
K772306wien laboratories125I DIGOXIN TEST SETDecember 22, 1977
K771525diagnostic products125 I DIGOXIN RIA KITOctober 14, 1977
K760883nuclear medical laboratoriesDIGI-TAB-RIA DIGOXIN RADIOMMUNOASSAYNovember 19, 1976