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FDA 510(k)

Alinity i STAT High Sensitivity Troponin-I

K-Number: K202525 · 2022-05-19

ApplicantAbbott Laboratories Diagnostics Division
Decision Date2022-05-19
Product CodeMMI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Alinity i STAT High Sensitivity Troponin-I is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories Diagnostics Division. It received FDA 510(k) clearance on 2022-05-19 under 510(k) number K202525. 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 Alinity i STAT High Sensitivity Troponin-I?

Alinity i STAT High Sensitivity Troponin-I is a medical device that received FDA 510(k) clearance on 2022-05-19. The listed applicant is Abbott Laboratories Diagnostics Division. The 510(k) number is K202525.

When did Alinity i STAT High Sensitivity Troponin-I receive FDA 510(k) clearance?

Alinity i STAT High Sensitivity Troponin-I received FDA 510(k) clearance on 2022-05-19, under 510(k) number K202525.

Who is the listed applicant for Alinity i STAT High Sensitivity Troponin-I?

The FDA 510(k) record lists Abbott Laboratories Diagnostics Division as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Alinity i STAT High Sensitivity Troponin-I?

The FDA product code for Alinity i STAT High Sensitivity Troponin-I is MMI.

Related Clinical Trials

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.

NCT06899776Assessing Chest Pain Using Point-of-Care High-Sensitivity Troponin I in the Emergency DepartmentACTIVE_NOT_RECRUITING

Other records listing Abbott Laboratories Diagnostics Division 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.

K240468Alkaline PhosphataseK230994Alinity i STAT High Sensitivity Troponin-IK191595ARCHITECT STAT High Sensitivity Troponin-I

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.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.

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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