FDA 510(k)

Access CK-MB

K-Number: K234005 · 2024-02-16

Decision Date2024-02-16

Product CodeJHX

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

Access CK-MB is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2024-02-16 under 510(k) number K234005. The device is classified under product code JHX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Access CK-MB?

Access CK-MB is a medical device that received FDA 510(k) clearance on 2024-02-16. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K234005.

When did Access CK-MB receive FDA 510(k) clearance?

Access CK-MB received FDA 510(k) clearance on 2024-02-16, under 510(k) number K234005.

Who is the listed applicant for Access CK-MB?

The FDA 510(k) record lists Beckman Coulter, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Access CK-MB?

The FDA product code for Access CK-MB is JHX.

Other records listing Beckman Coulter, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.