Cleared Traditional

Access Testosterone

K223405 · Beckman Coulter, Inc. · Chemistry
Jan 2023
Decision
65d
Days
Class 1
Risk

About This 510(k) Submission

K223405 is an FDA 510(k) clearance for the Access Testosterone, 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 January 13, 2023, 65 days after receiving the submission on November 9, 2022. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1680.

Submission Details

510(k) Number K223405 FDA.gov
FDA Decision Cleared SESE
Date Received November 09, 2022
Decision Date January 13, 2023
Days to Decision 65 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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