Product code LNW— Clinical Chemistry

PHEM-ALERT

Classification name
Paper, Obstetric Ph
Device class
Class 1
Regulation
21 CFR 862.1550
Advisory panel
Clinical Chemistry
Total cleared
4
First cleared
Most recent

Market context for product code LNW

FDA has cleared 4 devices under product code LNW between 1985 and 2003, filed by 3 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 LNW

Recent clearances under product code LNW

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