CDZ

Radioimmunoassay, Testosterones And Dihydrotestosterone

Product code
CDZ
Device name
Radioimmunoassay, Testosterones And Dihydrotestosterone
Device class
Class 1
21 CFR
21 CFR 862.1680
Medical specialty
Clinical Chemistry
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
3
Summaries archived here
3 (direct download)
510(k) clearances (all years, FDA)
89 (all years; only the last 3 years are listed here)

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

Last three years. Most recent: 2026-04-15.

NumberDecision dateApplicantDevice nameSummary
K2527282026-04-15Immunodiagnostic Systems LimitedIDS-iSYS Total TestosteronePDF
K2408652024-10-23Immunodiagnostic Systems LimitedIDS-iSYS Free TestosteronePDF
K2334802024-02-08Beckman Coulter, Inc.Access SHBGPDF

3 summaries are archived here for direct download.

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