DeviceClearance

Product code CGN— Clinical Chemistry

ABBOTT ARCHITECT FOLATE

Classification name
Acid, Folic, Radioimmunoassay
Device class
Class 2
Regulation
21 CFR 862.1295
Advisory panel
Clinical Chemistry
Total cleared
64
First cleared
Most recent

Market context for product code CGN

FDA has cleared 64 devices under product code CGN between 1976 and 2024, 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 CGN

Recent clearances under product code CGN

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