GRO

Antisera, Fluorescent, All Types, Hemophilus Spp.

Product code: GRO
Device name: Antisera, Fluorescent, All Types, Hemophilus Spp.
Device class: Class 2
21 CFR: 21 CFR 866.3300
Medical specialty: Microbiology
Marketing pathway: 510(K) Exempt
510(k) clearances (all years, FDA): 4 (all years; only the last 3 years are listed here)

Official FDA classification page: GRO

Classification and pathway per current FDA publications. Data from openFDA (CC0).