DeviceClearance

Product code CDD— Clinical Chemistry

VITAMIN B12 RADIOASSAY

Classification name
Radioassay, Vitamin B12
Device class
Class 2
Regulation
21 CFR 862.1810
Advisory panel
Clinical Chemistry
Total cleared
78
First cleared
Most recent

Market context for product code CDD

FDA has cleared 78 devices under product code CDD between 1976 and 2024, filed by 45 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 CDD

Recent clearances under product code CDD

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