MJE — Culture Media, Antifungal, Susceptibility Test Class II

FDA Device Classification

FDA product code MJE covers "Culture Media, Antifungal, Susceptibility Test", a Class II medical device regulated under 21 CFR 866.1700. Submissions are reviewed by the Microbiology panel. At least 1 recent 510(k) clearance has been granted under this product code.

Classification Details

Product Code
MJE
Device Class
Class II
Regulation Number
866.1700
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K072827remelRPMI 1640 AGAR W/MOPS AND 2% GLUCOSENovember 26, 2007