DeviceClearance

Product code DKZ— Clinical Toxicology

CEDIA DAU AMPHETAMINES ASSAY

Classification name
Enzyme Immunoassay, Amphetamine
Device class
Class 2
Regulation
21 CFR 862.3100
Advisory panel
Clinical Toxicology
Total cleared
225
First cleared
Most recent

Market context for product code DKZ

FDA has cleared 225 devices under product code DKZ between 1976 and 2024, filed by 87 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 DKZ

Recent clearances under product code DKZ

1–100 of 225

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