DeviceClearance

Product code JKR— Clinical Chemistry

CALCITONIN RIA KIT

Classification name
Radioimmunoassay, Calcitonin
Device class
Class 2
Regulation
21 CFR 862.1140
Advisory panel
Clinical Chemistry
Total cleared
20
First cleared
Most recent

Market context for product code JKR

FDA has cleared 20 devices under product code JKR between 1979 and 2026, filed by 13 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 JKR

Recent clearances under product code JKR

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