Product code DMN— Clinical Toxicology

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Classification name
Thin Layer Chromatography, Cocaine
Device class
Class 2
Regulation
21 CFR 862.3250
Advisory panel
Clinical Toxicology
Total cleared
2
First cleared
Most recent

Market context for product code DMN

FDA has cleared 2 devices under product code DMN between 1989 and 1997, filed by 2 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 DMN

Recent clearances under product code DMN

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