DeviceClearance

Product code JLP— Clinical Chemistry

OVEIA (TM) DUAL ANALYTE

Classification name
Spectrophotometric Method, Pregnanediol
Device class
Class 1
Regulation
21 CFR 862.1605
Advisory panel
Clinical Chemistry
Total cleared
1
First cleared
Most recent

Market context for product code JLP

FDA has cleared 1 device under product code JLP, all in 1988, filed by 1 applicant company. 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.

Top applicants under product code JLP

Recent clearances under product code JLP

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