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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 a medical device manufactured by Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2019-05-17 under approval 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. It is manufactured by Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K190675.

When was Dimension EXL High-Sensitivity Troponin I (TNIH) Assay approved by the FDA?

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

What company makes Dimension EXL High-Sensitivity Troponin I (TNIH) Assay?

Dimension EXL High-Sensitivity Troponin I (TNIH) Assay is manufactured by Siemens Healthcare Diagnostics, Inc..

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.

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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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