Cleared Traditional

IDS SHBG

K190121 · Immunodiagnostic Systems , Ltd. · Chemistry
Jun 2019
Decision
143d
Days
Class 1
Risk

About This 510(k) Submission

K190121 is an FDA 510(k) clearance for the IDS SHBG, a Radioimmunoassay, Testosterones And Dihydrotestosterone (Class I — General Controls, product code CDZ), submitted by Immunodiagnostic Systems , Ltd. (Boldon, GB). The FDA issued a Cleared decision on June 17, 2019, 143 days after receiving the submission on January 25, 2019. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1680.

Submission Details

510(k) Number K190121 FDA.gov
FDA Decision Cleared SESE
Date Received January 25, 2019
Decision Date June 17, 2019
Days to Decision 143 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CDZ — Radioimmunoassay, Testosterones And Dihydrotestosterone
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1680