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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 the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2025-08-01 under 510(k) 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. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K243483.

When did Access hsTnI receive FDA 510(k) clearance?

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

Who is the listed applicant for Access hsTnI?

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 hsTnI?

The FDA product code for Access hsTnI is MMI.

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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Related Devices (Code: MMI)

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.

K253051i-STAT hs-TnI cartridge with the i-STAT Alinity SystemAbbott Point of Care, Inc.K252393VITROS Immunodiagnostic Products hs Troponin I Reagent PackOrtho-Clinical Diagnostics, Inc.K242870Access hsTnIBeckman Coulter, Inc.K240984i-STAT hs-TnI cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.K241165Atellica® IM High-Sensitivity Troponin I (TnIH)Siemens Healthcare Diagnostics, Inc.K231974PATHFAST®hs-cTnI-IIPhc Corporation

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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