FDA Product Code JHI: Visual, Pregnancy Hcg, Prescription Use
Leading manufacturers include Innovita (Tangshan) Biological Technology Co., Ltd..
FDA 510(k) Cleared Visual, Pregnancy Hcg, Prescription Use Devices (Product Code JHI)
About Product Code JHI - Regulatory Context
510(k) Submission Activity
375 total 510(k) submissions under product code JHI since 1976, with 375 receiving FDA clearance (average review time: 70 days).
Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under JHI have taken an average of 32 days to reach a decision - down from 71 days historically, suggesting improved FDA processing for this classification.
JHI devices are reviewed by the Chemistry panel. Browse all Chemistry devices →