Product code DDD— Immunology

OLYMPUS TRANSFERRIN IMMUNOTURBIDIMETRIC REAGENT

Classification name
Transferrin, Rhodamine, Antigen, Antiserum, Control
Device class
Class 2
Regulation
21 CFR 866.5880
Advisory panel
Immunology
Total cleared
1
First cleared
Most recent

Market context for product code DDD

FDA has cleared 1 device under product code DDD, all in 1997, 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 DDD

Recent clearances under product code DDD

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