Cleared Traditional

Access Folate Assay

K223590 · Beckman Coulter, Inc. · Chemistry
Aug 2023
Decision
265d
Days
Class 2
Risk

About This 510(k) Submission

K223590 is an FDA 510(k) clearance for the Access Folate Assay, a Acid, Folic, Radioimmunoassay (Class II — Special Controls, product code CGN), submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on August 23, 2023, 265 days after receiving the submission on December 1, 2022. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1295.

Submission Details

510(k) Number K223590 FDA.gov
FDA Decision Cleared SESE
Date Received December 01, 2022
Decision Date August 23, 2023
Days to Decision 265 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CGN — Acid, Folic, Radioimmunoassay
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1295

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