Access CK-MB
K-Number: K234005 · 2024-02-16
ApplicantBeckman Coulter, Inc.
Decision Date2024-02-16
Product CodeJHX
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
Access CK-MB is a medical device manufactured by Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2024-02-16 under approval 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. It is manufactured by Beckman Coulter, Inc.. The 510(k) number is K234005.
When was Access CK-MB approved by the FDA?
Access CK-MB received FDA 510(k) clearance on 2024-02-16, under approval number K234005.
What company makes Access CK-MB?
Access CK-MB is manufactured by Beckman Coulter, Inc..
What is the FDA product code for Access CK-MB?
The FDA product code for Access CK-MB is JHX.
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Related Devices (Code: JHX)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.