Cleared Abbreviated

ACCESS DHEA-S REAGENT ASSAY

K040181 · Beckman Coulter, Inc. · Chemistry
Mar 2004
Decision
57d
Days
Class 1
Risk

About This 510(k) Submission

K040181 is an FDA 510(k) clearance for the ACCESS DHEA-S REAGENT ASSAY, a Radioimmunoassay, Dehydroepiandrosterone (free And Sulfate) (Class I — General Controls, product code JKC), submitted by Beckman Coulter, Inc. (Brea, US). The FDA issued a Cleared decision on March 24, 2004, 57 days after receiving the submission on January 27, 2004. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1245.

Submission Details

510(k) Number K040181 FDA.gov
FDA Decision Cleared SESE
Date Received January 27, 2004
Decision Date March 24, 2004
Days to Decision 57 days
Submission Type Abbreviated
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JKC — Radioimmunoassay, Dehydroepiandrosterone (free And Sulfate)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1245

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