LTX — Discs, Elution Class II

FDA Device Classification

Classification Details

Product Code
LTX
Device Class
Class II
Regulation Number
866.1620
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K002139ab biodiskETEST LINEZOLIDNovember 8, 2000
K992993ab biodiskETEST FOR QUINUPRISTIN/DALFOPRISTINNovember 16, 1999