Cleared Traditional

Access sTfR

K240987 · Beckman Coulter, Inc. · Immunology
Jul 2024
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K240987 is an FDA 510(k) clearance for the Access sTfR, a Transferrin, Antigen, Antiserum, Control (Class II — Special Controls, product code DDG), submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on July 3, 2024, 84 days after receiving the submission on April 10, 2024. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5880.

Submission Details

510(k) Number K240987 FDA.gov
FDA Decision Cleared SESE
Date Received April 10, 2024
Decision Date July 03, 2024
Days to Decision 84 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DDG — Transferrin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5880

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