GMN — Antigens, Cf, Toxoplasma Gondii Class II

FDA Device Classification

FDA product code GMN covers "Antigens, Cf, Toxoplasma Gondii", a Class II medical device regulated under 21 CFR 866.3780. 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
GMN
Device Class
Class II
Regulation Number
866.3780
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K894261microbix biosystemsTOXOPLASMA GONDII-CF ANTIGEN AND CONTROL ANTIGENOctober 16, 1989
K864981virion (u.s.)TOXOPLASMA GONDIIOctober 30, 1987
K791456volu sol medical industriesAGGLUTINOTEST-TOXOPLASMOSISSeptember 24, 1979