DPJ — Radioimmunoassay, Amphetamine (125-I), Goat Antibody, Ammonium Sulfate Sep. Class II

FDA Device Classification

FDA product code DPJ covers "Radioimmunoassay, Amphetamine (125-I), Goat Antibody, Ammonium Sulfate Sep.", a Class II medical device regulated under 21 CFR 862.3100. Submissions are reviewed by the Clinical Toxicology panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
DPJ
Device Class
Class II
Regulation Number
862.3100
Submission Type
Review Panel
TX
Medical Specialty
Clinical Toxicology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K913911roche diagnostic systemsABUSCREEN(R) RADIOIMMUNOASSAY FOR METHAMPHE/AMPHETNovember 1, 1991
K912754roche diagnostic systemsABUSCREEN RADIOIMMUNOASSAY FOR METHAMPHETAMINESeptember 27, 1991