Product code IGB— Pathology

SAF FIXATIVE

Classification name
Solution, Formalin-Sodium Acetate
Device class
Class 1
Regulation
21 CFR 864.4010
Advisory panel
Pathology
Total cleared
1
First cleared
Most recent

Market context for product code IGB

FDA has cleared 1 device under product code IGB, all in 1980, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code IGB

Recent clearances under product code IGB

Data sourced from openFDA. This site is unofficial and independent of the FDA.