DeviceClearance

Product code DNN— Clinical Toxicology

ETHYL ALCOHOL CLINICAL STANDARD SOLUTIONS

Classification name
Calibrators, Ethyl Alcohol
Device class
Class 2
Regulation
21 CFR 862.3200
Advisory panel
Clinical Toxicology
Total cleared
7
First cleared
Most recent

Market context for product code DNN

FDA has cleared 7 devices under product code DNN between 1980 and 1999, filed by 5 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 DNN

Recent clearances under product code DNN

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