DJK — Digitoxin Control Serum, Ria Class I

FDA Device Classification

FDA product code DJK covers "Digitoxin Control Serum, Ria", a Class I medical device regulated under 21 CFR 862.3280. Submissions are reviewed by the Clinical Toxicology panel. At least 1 recent 510(k) clearance has been granted under this product code.

Classification Details

Product Code
DJK
Device Class
Class I
Regulation Number
862.3280
Submission Type
Review Panel
TX
Medical Specialty
Clinical Toxicology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K780495diagnostic productsDIGITOXINApril 10, 1978