Cleared Traditional

Access Myoglobin

K231832 · Beckman Coulter, Inc. · Chemistry
Sep 2023
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K231832 is an FDA 510(k) clearance for the Access Myoglobin, a Myoglobin, Antigen, Antiserum, Control (Class II — Special Controls, product code DDR), submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on September 18, 2023, 88 days after receiving the submission on June 22, 2023. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.5680.

Submission Details

510(k) Number K231832 FDA.gov
FDA Decision Cleared SESE
Date Received June 22, 2023
Decision Date September 18, 2023
Days to Decision 88 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code DDR — Myoglobin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5680

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