DeviceClearance

Product code DIH— Clinical Toxicology

ADVIA 1650 CHOLINESTERASE ASSAY

Classification name
Colorimetry, Cholinesterase
Device class
Class 1
Regulation
21 CFR 862.3240
Advisory panel
Clinical Toxicology
Total cleared
26
First cleared
Most recent

Market context for product code DIH

FDA has cleared 26 devices under product code DIH between 1979 and 2011, filed by 22 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 DIH

Recent clearances under product code DIH

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