GRO — Antisera, Fluorescent, All Types, Hemophilus Spp. Class II

FDA Device Classification

Classification Details

Product Code
GRO
Device Class
Class II
Regulation Number
866.3300
Submission Type
Review Panel
MI
Medical Specialty
Microbiology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K851271gen-probeLEGIONELLA CULTURE CONFIRMATIN KITJuly 8, 1985
K834067remelLEGIONELLA DIFFERENTIATION DISKJanuary 3, 1984
K802423pharmaciaPHADEBACT HAEMOPHILUS TESTNovember 12, 1980
K800493armkelBACTOGEN-H. INFLUENZAE TYPE BApril 4, 1980