Product code DPJ— Clinical Toxicology

ABUSCREEN RADIOIMMUNOASSAY FOR METHAMPHETAMINE

Classification name
Radioimmunoassay, Amphetamine (125-I), Goat Antibody, Ammonium Sulfate Sep.
Device class
Class 2
Regulation
21 CFR 862.3100
Advisory panel
Clinical Toxicology
Total cleared
2
First cleared
Most recent

Market context for product code DPJ

FDA has cleared 2 devices under product code DPJ, all in 1991, filed by 1 applicant company. 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 DPJ

Recent clearances under product code DPJ

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