DeviceClearance

Product code DNJ— Clinical Toxicology

DIGOXIN RIA KIT

Classification name
Radioimmunoassay, Digoxin (125-I), Goat Antibody, 2nd Antibody Sep.
Device class
Class 2
Regulation
21 CFR 862.3320
Advisory panel
Clinical Toxicology
Total cleared
2
First cleared
Most recent

Market context for product code DNJ

FDA has cleared 2 devices under product code DNJ, all in 1977, filed by 2 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.

Top applicants under product code DNJ

Recent clearances under product code DNJ

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