DPG — Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Coated Tube Sep. Class II

FDA Device Classification

FDA product code DPG covers "Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Coated Tube Sep.", a Class II medical device regulated under 21 CFR 862.3300. Submissions are reviewed by the Clinical Toxicology panel. At least 3 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
DPG
Device Class
Class II
Regulation Number
862.3300
Submission Type
Review Panel
TX
Medical Specialty
Clinical Toxicology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K935229pb diagnostic systemsOPUS DIGITOXINDecember 22, 1993
K812129diagnostic productsCOAT-A-COUNT DIGITOXIN RIA KITAugust 13, 1981
K780075miles laboratoriesRIALYZE DIGOXINFebruary 28, 1978