LAG — High Pressure Liquid Chromatography, Methamphetamine Class II

FDA Device Classification

FDA product code LAG covers "High Pressure Liquid Chromatography, Methamphetamine", a Class II medical device regulated under 21 CFR 862.3610. Submissions are reviewed by the Clinical Toxicology panel. At least 4 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
LAG
Device Class
Class II
Regulation Number
862.3610
Submission Type
Review Panel
TX
Medical Specialty
Clinical Toxicology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K073078american bio medicaRAPID TOX CUPMay 30, 2008
K062575princeton biomeditechMODIFICATION TO: ACCUSIGN RC DOA 10 (MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/AMPNovember 26, 2007
K990786princeton biomeditechACCUSIGN DOA 10, ACCUSIGN DOA 10 PANEL, ACUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/March 26, 1999
K983501princeton biomeditechACCUSIGN DOA 10,ACCUSIGN DOA PANEL,ACCUSIGN MET/OPI/COC/THC/PCP/BZO/BAR/MTD/TCA/December 18, 1998