DeviceClearance

Product code KQO— Clinical Chemistry

CHEMSTRIP URINE ANALYZER

Classification name
Automated Urinalysis System
Device class
Class 1
Regulation
21 CFR 862.2900
Advisory panel
Clinical Chemistry
Total cleared
46
First cleared
Most recent

Market context for product code KQO

FDA has cleared 46 devices under product code KQO between 1976 and 2015, filed by 25 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 KQO

Recent clearances under product code KQO

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