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FDA 510(k)

Atellica IM High-Sensitivity Troponin I (TNIH)

K-Number: K171566 · 2018-07-19

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2018-07-19
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 2018-07-19 under approval number K171566. 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 2018-07-19. It is manufactured by Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K171566.

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 2018-07-19, under approval number K171566.

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 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 K190675Dimension EXL High-Sensitivity Troponin I (TNIH) AssaySiemens 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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