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FDA 510(k)

Elecsys Troponin T Gen 5

K-Number: K201441 · 2021-09-21

ApplicantRoche Diagnostics
Decision Date2021-09-21
Product CodeMMI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Elecsys Troponin T Gen 5 is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics. It received FDA 510(k) clearance on 2021-09-21 under 510(k) number K201441. 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 Elecsys Troponin T Gen 5?

Elecsys Troponin T Gen 5 is a medical device that received FDA 510(k) clearance on 2021-09-21. The listed applicant is Roche Diagnostics. The 510(k) number is K201441.

When did Elecsys Troponin T Gen 5 receive FDA 510(k) clearance?

Elecsys Troponin T Gen 5 received FDA 510(k) clearance on 2021-09-21, under 510(k) number K201441.

Who is the listed applicant for Elecsys Troponin T Gen 5?

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

What is the FDA product code for Elecsys Troponin T Gen 5?

The FDA product code for Elecsys Troponin T Gen 5 is MMI.

Other records listing Roche Diagnostics as applicant

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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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