DeviceClearance

Product code DIO— Clinical Toxicology

CEDIA DAU COCAINE ASSAY

Classification name
Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Device class
Class 2
Regulation
21 CFR 862.3250
Advisory panel
Clinical Toxicology
Total cleared
145
First cleared
Most recent

Market context for product code DIO

FDA has cleared 145 devices under product code DIO between 1984 and 2022, filed by 71 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 DIO

Recent clearances under product code DIO

1–100 of 145

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