GSJ — Antiserum, Fluorescent, Francisella Tularensis Class II

FDA Device Classification

FDA product code GSJ covers "Antiserum, Fluorescent, Francisella Tularensis", a Class II medical device regulated under 21 CFR 866.3280. 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
GSJ
Device Class
Class II
Regulation Number
866.3280
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K914872marlo surgical technologyMARLOW SUCTION/IRRIGATION PROBESNovember 19, 1991