Cleared Traditional

IDS-iSYS Free Testosterone

K240865 · Immunodiagnostic Systems Limited · Chemistry

Oct 2024

Decision

209d

Days

Class 1

Risk

About This 510(k) Submission

K240865 is an FDA 510(k) clearance for the IDS-iSYS Free Testosterone, a Radioimmunoassay, Testosterones And Dihydrotestosterone (Class I — General Controls, product code CDZ), submitted by Immunodiagnostic Systems Limited (Tyne & Wear, GB). The FDA issued a Cleared decision on October 23, 2024, 209 days after receiving the submission on March 28, 2024. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1680.

Submission Details

510(k) Number	K240865 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 28, 2024
Decision Date	October 23, 2024
Days to Decision	209 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF