DeviceClearance

Product code CEF— Clinical Chemistry

AMIDO BLACK CONCENTRATE

Classification name
Electrophoretic, Protein Fractionation
Device class
Class 1
Regulation
21 CFR 862.1630
Advisory panel
Clinical Chemistry
Total cleared
29
First cleared
Most recent

Market context for product code CEF

FDA has cleared 29 devices under product code CEF between 1977 and 2013, filed by 9 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 CEF

Recent clearances under product code CEF

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