DNI — Liquid Chromatography, Amphetamine Class II

FDA Device Classification

FDA product code DNI covers "Liquid Chromatography, Amphetamine", a Class II medical device regulated under 21 CFR 862.3100. 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
DNI
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
K941596bio-radREMEDI HS DRUG PROFILING SYSTEMMarch 27, 1995