GIE

Fibrometer

Product code
GIE
Device name
Fibrometer
Device class
Class 2
21 CFR
21 CFR 864.5400
Medical specialty
Hematology
Marketing pathway
510(K) Exempt
510(k) clearances (all years, FDA)
2 (all years; only the last 3 years are listed here)
Official FDA classification page: GIE
Classification and pathway per current FDA publications. Data from openFDA (CC0).