IGE

Solution, Formalin Ammonium Bromide

Product code
IGE
Device name
Solution, Formalin Ammonium Bromide
Device class
Class 1
21 CFR
21 CFR 864.4010
Medical specialty
Pathology
Marketing pathway
510(K) Exempt
Flag
GMP exempt
510(k) clearances (all years, FDA)
2 (all years; only the last 3 years are listed here)
Official FDA classification page: IGE
Classification and pathway per current FDA publications. Data from openFDA (CC0).