DIY — Gas Chromatography, Ethosuximide Class II

FDA Device Classification

FDA product code DIY covers "Gas Chromatography, Ethosuximide", a Class II medical device regulated under 21 CFR 862.3380. 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
DIY
Device Class
Class II
Regulation Number
862.3380
Submission Type
Review Panel
TX
Medical Specialty
Clinical Toxicology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K780734vitek systemsANTICONVULSANTS II CALIBRATOR KITJune 22, 1978