DeviceClearance

Product code DDR— Immunology

MYOGLOBIN RIA TEST KIT

Classification name
Myoglobin, Antigen, Antiserum, Control
Device class
Class 2
Regulation
21 CFR 866.5680
Advisory panel
Immunology
Total cleared
46
First cleared
Most recent

Market context for product code DDR

FDA has cleared 46 devices under product code DDR between 1977 and 2023, filed by 34 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 DDR

Recent clearances under product code DDR

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