DeviceClearance

Product code KDW— Pathology

CAPITOL URINE DRUG SCREEN COLLECTION KIT

Classification name
Container, Specimen Mailer And Storage, Temperature Controlled, Sterile
Device class
Class 1
Regulation
21 CFR 864.3250
Advisory panel
Pathology
Total cleared
4
First cleared
Most recent

Market context for product code KDW

FDA has cleared 4 devices under product code KDW between 1991 and 1997, filed by 4 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 KDW

Recent clearances under product code KDW

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