DeviceClearance

Product code CHP— Clinical Chemistry

ESTRADIOL KIT BY RIA

Classification name
Radioimmunoassay, Estradiol
Device class
Class 1
Regulation
21 CFR 862.1260
Advisory panel
Clinical Chemistry
Total cleared
50
First cleared
Most recent

Market context for product code CHP

FDA has cleared 50 devices under product code CHP between 1979 and 2004, filed by 34 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

last 15 years

Top applicants under product code CHP

Recent clearances under product code CHP

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