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FDA 510(k)

Atellica® IM High-Sensitivity Troponin I (TnIH)

K-Number: K241165 · 2024-07-25

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2024-07-25
Product CodeMMI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Atellica® IM High-Sensitivity Troponin I (TnIH) is a medical device manufactured by Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2024-07-25 under approval number K241165. 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 Atellica® IM High-Sensitivity Troponin I (TnIH)?

Atellica® IM High-Sensitivity Troponin I (TnIH) is a medical device that received FDA 510(k) clearance on 2024-07-25. It is manufactured by Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K241165.

When was Atellica® IM High-Sensitivity Troponin I (TnIH) approved by the FDA?

Atellica® IM High-Sensitivity Troponin I (TnIH) received FDA 510(k) clearance on 2024-07-25, under approval number K241165.

What company makes Atellica® IM High-Sensitivity Troponin I (TnIH)?

Atellica® IM High-Sensitivity Troponin I (TnIH) is manufactured by Siemens Healthcare Diagnostics, Inc..

What is the FDA product code for Atellica® IM High-Sensitivity Troponin I (TnIH)?

The FDA product code for Atellica® IM High-Sensitivity Troponin I (TnIH) is MMI.

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Related Devices (Code: MMI)

K162895Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Troponin T Gen 5 CalCheck 5Roche Diagnostics K171566Atellica IM High-Sensitivity Troponin I (TNIH)Siemens Healthcare Diagnostics, Inc. K171274ADVIA Centaur High-Sensitivity Troponin I (TNIH)Siemens Healthcare Diagnostics, Inc. K172787Access hsTnlBeckman Coulter, Inc. K172783Access hs TnlBeckman Coulter, Inc. K191595ARCHITECT STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division

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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