DeviceClearance

Product code KLB— Clinical Toxicology

TOBRAMYCIN RIA KIT

Classification name
Radioimmunoassay, Tobramycin
Device class
Class 2
Regulation
21 CFR 862.3900
Advisory panel
Clinical Toxicology
Total cleared
23
First cleared
Most recent

Market context for product code KLB

FDA has cleared 23 devices under product code KLB between 1976 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

last 15 years

Top applicants under product code KLB

Recent clearances under product code KLB

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