LOP — Solution, Antimicrobial Class II

FDA Device Classification

FDA product code LOP covers "Solution, Antimicrobial", a Class II medical device regulated under 21 CFR 866.1640. Submissions are reviewed by the Microbiology panel. At least 3 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
LOP
Device Class
Class II
Regulation Number
866.1640
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K902004upjohnTROBICIN SUSCEPTIBILITY POWDERMay 15, 1990
K900455upjohnZEFAZONE SUSCEPTIBILITY POWDERFebruary 9, 1990
K810471cathra internationalSTOCK ANTIMICROBIC SOLUTIONSApril 1, 1981