Cleared Traditional

Access CK-MB

K234005 · Beckman Coulter, Inc. · Chemistry
Feb 2024
Decision
59d
Days
Class 2
Risk

About This 510(k) Submission

K234005 is an FDA 510(k) clearance for the Access CK-MB, a Fluorometric Method, Cpk Or Isoenzymes (Class II — Special Controls, product code JHX), submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on February 16, 2024, 59 days after receiving the submission on December 19, 2023. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1215.

Submission Details

510(k) Number K234005 FDA.gov
FDA Decision Cleared SESE
Date Received December 19, 2023
Decision Date February 16, 2024
Days to Decision 59 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JHX — Fluorometric Method, Cpk Or Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1215

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