GRT — Antiserum, Fluorescent, Mycobacterium Tuberculosis Class I

FDA Device Classification

FDA product code GRT covers "Antiserum, Fluorescent, Mycobacterium Tuberculosis", a Class I medical device regulated under 21 CFR 866.3370. 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
GRT
Device Class
Class I
Regulation Number
866.3370
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K791452volu sol medical industriesAGGLUTINOTEST-TUBERCULOSISSeptember 24, 1979