DeviceClearance

Product code CFL— Clinical Chemistry

ACTIVE IGF-I ELISA

Classification name
Radioimmunoassay, Human Growth Hormone
Device class
Class 1
Regulation
21 CFR 862.1370
Advisory panel
Clinical Chemistry
Total cleared
36
First cleared
Most recent

Market context for product code CFL

FDA has cleared 36 devices under product code CFL between 1978 and 1997, filed by 20 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 CFL

Recent clearances under product code CFL

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