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FDA 510(k)

ADVIA Centaur High-Sensitivity Troponin I (TNIH)

K-Number: K171274 · 2018-07-12

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2018-07-12
Product CodeMMI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ADVIA Centaur High-Sensitivity Troponin I (TNIH) 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 2018-07-12 under 510(k) number K171274. 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 ADVIA Centaur High-Sensitivity Troponin I (TNIH)?

ADVIA Centaur High-Sensitivity Troponin I (TNIH) is a medical device that received FDA 510(k) clearance on 2018-07-12. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K171274.

When did ADVIA Centaur High-Sensitivity Troponin I (TNIH) receive FDA 510(k) clearance?

ADVIA Centaur High-Sensitivity Troponin I (TNIH) received FDA 510(k) clearance on 2018-07-12, under 510(k) number K171274.

Who is the listed applicant for ADVIA Centaur High-Sensitivity Troponin I (TNIH)?

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 ADVIA Centaur High-Sensitivity Troponin I (TNIH)?

The FDA product code for ADVIA Centaur High-Sensitivity Troponin I (TNIH) is MMI.

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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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