DeviceClearance

Product code JKL— Clinical Chemistry

DSL DHEA (DSL 8900)

Classification name
Acid, Delta-Aminolevulinic, Ion-Exchange Columns With Colorimetry
Device class
Class 1
Regulation
21 CFR 862.1060
Advisory panel
Clinical Chemistry
Total cleared
2
First cleared
Most recent

Market context for product code JKL

FDA has cleared 2 devices under product code JKL between 1984 and 1992, filed by 2 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

Top applicants under product code JKL

Recent clearances under product code JKL

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