Product code LDO— Clinical Toxicology

EMIT ASSAY AND TOBRAMYCIN

Classification name
Enzymatic Radiochemical Assay, Tobramycin
Device class
Class 2
Regulation
21 CFR 862.3900
Advisory panel
Clinical Toxicology
Total cleared
3
First cleared
Most recent

Market context for product code LDO

FDA has cleared 3 devices under product code LDO between 1983 and 2005, filed by 3 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 LDO

Recent clearances under product code LDO

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