JKR

Radioimmunoassay, Calcitonin

Product code
JKR
Device name
Radioimmunoassay, Calcitonin
Device class
Class 2
21 CFR
21 CFR 862.1140
Medical specialty
Clinical Chemistry
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
20 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2026-04-24.

NumberDecision dateApplicantDevice nameSummary
K2524312026-04-24Roche Diagnostics GmbHElecsys CalcitoninPDF

1 summaries are archived here for direct download.

Official FDA classification page: JKR
Classification and pathway per current FDA publications. Data from openFDA (CC0).