DeviceClearance

Product code JKC— Clinical Chemistry

125 I-DEHYDROEPIANDROSTERONE SULFATE

Classification name
Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)
Device class
Class 1
Regulation
21 CFR 862.1245
Advisory panel
Clinical Chemistry
Total cleared
28
First cleared
Most recent

Market context for product code JKC

FDA has cleared 28 devices under product code JKC between 1979 and 2004, filed by 17 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 JKC

Recent clearances under product code JKC

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