DeviceClearance

Product code DLJ— Clinical Toxicology

SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS

Classification name
Calibrators, Drug Specific
Device class
Class 2
Regulation
21 CFR 862.3200
Advisory panel
Clinical Toxicology
Total cleared
123
First cleared
Most recent

Market context for product code DLJ

FDA has cleared 123 devices under product code DLJ between 1977 and 2013, filed by 30 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 DLJ

Recent clearances under product code DLJ

1–100 of 123

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