DKX — Thin Layer Chromatography, Barbiturate Class II

FDA Device Classification

FDA product code DKX covers "Thin Layer Chromatography, Barbiturate", a Class II medical device regulated under 21 CFR 862.3150. 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
DKX
Device Class
Class II
Regulation Number
862.3150
Submission Type
Review Panel
TX
Medical Specialty
Clinical Toxicology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K030211icn biomedicalsRAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016June 13, 2003
K800364hoffrel instrumentsULTRASONIC DIAGNOSTIC SYSTEM, MOD. 202March 12, 1980