DeviceClearance

Product code JXN— Clinical Toxicology

'RAPID ONE' - PROPOXYPHENE TEST

Classification name
Enzyme Immunoassay, Propoxyphene
Device class
Class 2
Regulation
21 CFR 862.3700
Advisory panel
Clinical Toxicology
Total cleared
22
First cleared
Most recent

Market context for product code JXN

FDA has cleared 22 devices under product code JXN between 1985 and 2015, filed by 17 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 JXN

Recent clearances under product code JXN

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