DOY — Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep. Class II

FDA Device Classification

FDA product code DOY covers "Radioimmunoassay, Digoxin (3-H), Goat Antibody, 2nd Antibody Sep.", a Class II medical device regulated under 21 CFR 862.3320. Submissions are reviewed by the Clinical Toxicology panel. At least 5 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
DOY
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
K910154c.r. bardUSCI ILLUMEN-8 8F PTCA GUIDING CATHETERApril 9, 1991
K832396gish biomedicalCENTRAL VENOUS ACCESS CATHETER CVACAugust 31, 1983
K831239medical parametersWALRUS PERCUTANEOUS INTRODUCER SETMay 25, 1983
K831191medradVASCULAR CATHETERMay 9, 1983
K831188medradCONNECTOR TUBEMay 9, 1983