CEC

Radioimmunoassay, Free Thyroxine

Product code
CEC
Device name
Radioimmunoassay, Free Thyroxine
Device class
Class 2
21 CFR
21 CFR 862.1695
Medical specialty
Clinical Chemistry
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
92

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

Last three years. Most recent: 2024-03-06.

NumberDecision dateApplicantDevice nameSummary
K2402732024-03-06Beckman Coulter, Inc.Access Free T4PDF

1 summaries are archived here for direct download.

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