Cleared Traditional

Access BR Monitor

K240403 · Beckman Coulter, Inc. · Immunology
May 2024
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K240403 is an FDA 510(k) clearance for the Access BR Monitor, a System, Test, Immunological, Antigen, Tumor (Class II — Special Controls, product code MOI), submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on May 9, 2024, 90 days after receiving the submission on February 9, 2024. This device falls under the Immunology review panel. Regulated under 21 CFR 866.6010.

Submission Details

510(k) Number K240403 FDA.gov
FDA Decision Cleared SESE
Date Received February 09, 2024
Decision Date May 09, 2024
Days to Decision 90 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code MOI — System, Test, Immunological, Antigen, Tumor
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.6010

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