LAE — High Pressure Liquid Chromatography, Codeine Class II

FDA Device Classification

FDA product code LAE covers "High Pressure Liquid Chromatography, Codeine", a Class II medical device regulated under 21 CFR 862.3270. 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
LAE
Device Class
Class II
Regulation Number
862.3270
Submission Type
Review Panel
TX
Medical Specialty
Clinical Toxicology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K851480vygonVYGON GUEDEL AIRWAY 511 VYGON BERMANN/OROPHAR AIRWMay 7, 1985
K832590memMOUTH-TO-MOUTH SHIELD APPLICATOROctober 14, 1983