DeviceClearance

Product code DNK— Clinical Toxicology

CR3 Keyless Split Sample Cup Morphine - Methamphetamine

Classification name
Thin Layer Chromatography, Morphine
Device class
Class 2
Regulation
21 CFR 862.3640
Advisory panel
Clinical Toxicology
Total cleared
4
First cleared
Most recent

Market context for product code DNK

FDA has cleared 4 devices under product code DNK between 1986 and 2015, filed by 4 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

Top applicants under product code DNK

Recent clearances under product code DNK

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