Product code LCW— Clinical Toxicology

(125 I) DIGITOXIN RIA KIT

Classification name
Radioimmunoassay, Digitoxin (125-I)
Device class
Class 2
Regulation
21 CFR 862.3300
Advisory panel
Clinical Toxicology
Total cleared
3
First cleared
Most recent

Market context for product code LCW

FDA has cleared 3 devices under product code LCW between 1978 and 1984, 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 LCW

Recent clearances under product code LCW

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