DeviceClearance

Product code DKJ— Clinical Toxicology

PARAMAX SALICYLATE REAGENT

Classification name
Colorimetry, Salicylate
Device class
Class 2
Regulation
21 CFR 862.3830
Advisory panel
Clinical Toxicology
Total cleared
29
First cleared
Most recent

Market context for product code DKJ

FDA has cleared 29 devices under product code DKJ between 1981 and 2010, filed by 23 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code DKJ

Recent clearances under product code DKJ

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