DeviceClearance

Product code LCR— Clinical Toxicology

ACS TOBRAMYCIN

Classification name
Fluorescent Immunoassay, Tobramycin
Device class
Class 2
Regulation
21 CFR 862.3900
Advisory panel
Clinical Toxicology
Total cleared
17
First cleared
Most recent

Market context for product code LCR

FDA has cleared 17 devices under product code LCR between 1980 and 2006, 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

Top applicants under product code LCR

Recent clearances under product code LCR

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