DeviceClearance

Product code JLX— Clinical Chemistry

AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KIT

Classification name
Radioimmunoassay, 17-Hydroxyprogesterone
Device class
Class 1
Regulation
21 CFR 862.1395
Advisory panel
Clinical Chemistry
Total cleared
19
First cleared
Most recent

Market context for product code JLX

FDA has cleared 19 devices under product code JLX between 1977 and 2010, filed by 12 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 JLX

Recent clearances under product code JLX

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