DeviceClearance

Product code LDZ— Pathology

ATS PARA-SET MODIFIED PVA FIXATIVE SOLUTION

Classification name
Fixative, Alcohol 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 LDZ

FDA has cleared 8 devices under product code LDZ between 1978 and 1988, filed by 7 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 LDZ

Recent clearances under product code LDZ

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