DKH — Gas Chromatography, Diphenylhydantoin Class II

FDA Device Classification

FDA product code DKH covers "Gas Chromatography, Diphenylhydantoin", a Class II medical device regulated under 21 CFR 862.3350. 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
DKH
Device Class
Class II
Regulation Number
862.3350
Submission Type
Review Panel
TX
Medical Specialty
Clinical Toxicology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K801276e.i. dupont de nemours and coDUPONT PREP APPLI. FOR PHENOBARBITAL,June 20, 1980
K780733vitek systemsANTICONVULSANTS III CALIBRATOR KITJune 22, 1978