Product code IGE— Pathology
CB FORMALIN
- Classification name
- Solution, Formalin Ammonium Bromide
- Device class
- Class 1
- Regulation
- 21 CFR 864.4010
- Advisory panel
- Pathology
- Total cleared
- 2
- First cleared
- Most recent
Market context for product code IGE
FDA has cleared devices under product code IGE between 1984 and 1995, filed by 2 applicant companies. 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.
Clearances per year
- 1995
- 1984
Top applicants under product code IGE
Recent clearances under product code IGE
Data sourced from openFDA. This site is unofficial and independent of the FDA.