DeviceClearance

Product code JXM— Clinical Toxicology

CEDIA DAU BENZODIAZEPINE ASSAY

Classification name
Enzyme Immunoassay, Benzodiazepine
Device class
Class 2
Regulation
21 CFR 862.3170
Advisory panel
Clinical Toxicology
Total cleared
90
First cleared
Most recent

Market context for product code JXM

FDA has cleared 90 devices under product code JXM between 1979 and 2024, filed by 42 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 JXM

Recent clearances under product code JXM

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