Product code GGJ— Hematology
VISTA(R) HUMAN FOLLICLE-STIM HORMONE(HFSH) ASSAY
- Classification name
- Fluid, Diluting, White-Cell
- Device class
- Class 1
- Regulation
- 21 CFR 864.8200
- Advisory panel
- Hematology
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code GGJ
FDA has cleared device under product code GGJ, all in 1993, 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 GGJ
Recent clearances under product code GGJ
Data sourced from openFDA. This site is unofficial and independent of the FDA.