Cleared Traditional

Access SHBG

K233480 · Beckman Coulter, Inc. · Chemistry
Feb 2024
Decision
105d
Days
Class 1
Risk

About This 510(k) Submission

K233480 is an FDA 510(k) clearance for the Access SHBG, a Radioimmunoassay, Testosterones And Dihydrotestosterone (Class I — General Controls, product code CDZ), submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on February 8, 2024, 105 days after receiving the submission on October 26, 2023. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1680.

Submission Details

510(k) Number K233480 FDA.gov
FDA Decision Cleared SESE
Date Received October 26, 2023
Decision Date February 08, 2024
Days to Decision 105 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

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