Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Roche Diagnostics. It received FDA 510(k) clearance on 2021-09-21 under approval 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. It is manufactured by Roche Diagnostics. The 510(k) number is K201441.

When was Elecsys Troponin T Gen 5 approved by the FDA?

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

What company makes Elecsys Troponin T Gen 5?

Elecsys Troponin T Gen 5 is manufactured by Roche Diagnostics.

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 Devices by Roche Diagnostics

DEN150057Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5 K160915Elecsys CYFRA 21-1, Elecsys CYFRA 21-1 CalSet, PreciControl Tumor Marker K160910Elecsys Syphilis K153607ROMA Calculation Tool Using Elecsys Assays K160729Elecys BRAHMS PCT, Elecys BRAHMS PCT CalCheck 5 K152227Elecsys Cortisol II, Cortisol II CalSet

View all 70 devices →

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.

↑