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FDA 510(k)

i-STAT hs-TnI cartridge with the i-STAT Alinity System

K-Number: K253051 · 2026-06-11

ApplicantAbbott Point of Care, Inc.
Decision Date2026-06-11
Product CodeMMI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

i-STAT hs-TnI cartridge with the i-STAT Alinity System is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Point of Care, Inc.. It received FDA 510(k) clearance on 2026-06-11 under 510(k) number K253051. 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 i-STAT hs-TnI cartridge with the i-STAT Alinity System?

i-STAT hs-TnI cartridge with the i-STAT Alinity System is a medical device that received FDA 510(k) clearance on 2026-06-11. The listed applicant is Abbott Point of Care, Inc.. The 510(k) number is K253051.

When did i-STAT hs-TnI cartridge with the i-STAT Alinity System receive FDA 510(k) clearance?

i-STAT hs-TnI cartridge with the i-STAT Alinity System received FDA 510(k) clearance on 2026-06-11, under 510(k) number K253051.

Who is the listed applicant for i-STAT hs-TnI cartridge with the i-STAT Alinity System?

The FDA 510(k) record lists Abbott Point of Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for i-STAT hs-TnI cartridge with the i-STAT Alinity System?

The FDA product code for i-STAT hs-TnI cartridge with the i-STAT Alinity System is MMI.

Other records listing Abbott Point of Care, 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.

K261039i-STAT Crea cartridge with the i-STAT 1 SystemK244014i-STAT CG4+ cartridge with the i-STAT 1 SystemK240984i-STAT hs-TnI cartridge with the i-STAT 1 SystemK234143i-STAT TBI Cartridge with the i-STAT Alinity SystemK230300i-STAT CG8+ cartridge with the i-STAT 1 SystemK230285i-STAT CG8+ cartridge with the i-STAT 1 System

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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.

K252393VITROS Immunodiagnostic Products hs Troponin I Reagent PackOrtho-Clinical Diagnostics, Inc.K243483Access hsTnIBeckman Coulter, 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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