DeviceClearance

Product code KDX— Pathology

CAL-RITE

Classification name
Solution, Decalcifier, Acid Containing
Device class
Class 1
Regulation
21 CFR 864.4010
Advisory panel
Pathology
Total cleared
8
First cleared
Most recent

Market context for product code KDX

FDA has cleared 8 devices under product code KDX between 1981 and 1987, filed by 8 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 KDX

Recent clearances under product code KDX

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