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FDA 510(k)

Dimension EXL High-Sensitivity Troponin I (TNIH) Assay

K-Number: K190675 · 2019-05-17

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2019-05-17
Product CodeMMI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Dimension EXL High-Sensitivity Troponin I (TNIH) Assay is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2019-05-17 under 510(k) number K190675. 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 Dimension EXL High-Sensitivity Troponin I (TNIH) Assay?

Dimension EXL High-Sensitivity Troponin I (TNIH) Assay is a medical device that received FDA 510(k) clearance on 2019-05-17. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K190675.

When did Dimension EXL High-Sensitivity Troponin I (TNIH) Assay receive FDA 510(k) clearance?

Dimension EXL High-Sensitivity Troponin I (TNIH) Assay received FDA 510(k) clearance on 2019-05-17, under 510(k) number K190675.

Who is the listed applicant for Dimension EXL High-Sensitivity Troponin I (TNIH) Assay?

The FDA 510(k) record lists Siemens Healthcare Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dimension EXL High-Sensitivity Troponin I (TNIH) Assay?

The FDA product code for Dimension EXL High-Sensitivity Troponin I (TNIH) Assay 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

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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.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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