DeviceClearance

Product code DJR— Clinical Toxicology

METHADONE ENZYME IMMUNOASSAY

Classification name
Enzyme Immunoassay, Methadone
Device class
Class 2
Regulation
21 CFR 862.3620
Advisory panel
Clinical Toxicology
Total cleared
63
First cleared
Most recent

Market context for product code DJR

FDA has cleared 63 devices under product code DJR between 1984 and 2019, filed by 36 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 DJR

Recent clearances under product code DJR

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