DeviceClearance

Product code LPW— Clinical Chemistry

OXALATE REAGENT

Classification name
System, Test, Oxalate
Device class
Class 1
Regulation
21 CFR 862.1542
Advisory panel
Clinical Chemistry
Total cleared
1
First cleared
Most recent

Market context for product code LPW

FDA has cleared 1 device under product code LPW, 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 LPW

Recent clearances under product code LPW

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