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FDA 510(k)

Access hsTnI

K-Number: K243483 · 2025-08-01

ApplicantBeckman Coulter, Inc.
Decision Date2025-08-01
Product CodeMMI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Access hsTnI is a medical device manufactured by Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2025-08-01 under approval number K243483. The device is classified under product code MMI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Access hsTnI?

Access hsTnI is a medical device that received FDA 510(k) clearance on 2025-08-01. It is manufactured by Beckman Coulter, Inc.. The 510(k) number is K243483.

When was Access hsTnI approved by the FDA?

Access hsTnI received FDA 510(k) clearance on 2025-08-01, under approval number K243483.

What company makes Access hsTnI?

Access hsTnI is manufactured by Beckman Coulter, Inc..

What is the FDA product code for Access hsTnI?

The FDA product code for Access hsTnI is MMI.

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Related Devices (Code: MMI)

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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.

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