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)

Dimension Vista High-Sensitivity Troponin I (TNIH) Assay

K-Number: K182225 · 2019-03-04

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2019-03-04
Product CodeMMI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Dimension Vista High-Sensitivity Troponin I (TNIH) Assay is a medical device manufactured by Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2019-03-04 under approval number K182225. 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 Dimension Vista High-Sensitivity Troponin I (TNIH) Assay?

Dimension Vista High-Sensitivity Troponin I (TNIH) Assay is a medical device that received FDA 510(k) clearance on 2019-03-04. It is manufactured by Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K182225.

When was Dimension Vista High-Sensitivity Troponin I (TNIH) Assay approved by the FDA?

Dimension Vista High-Sensitivity Troponin I (TNIH) Assay received FDA 510(k) clearance on 2019-03-04, under approval number K182225.

What company makes Dimension Vista High-Sensitivity Troponin I (TNIH) Assay?

Dimension Vista High-Sensitivity Troponin I (TNIH) Assay is manufactured by Siemens Healthcare Diagnostics, Inc..

What is the FDA product code for Dimension Vista High-Sensitivity Troponin I (TNIH) Assay?

The FDA product code for Dimension Vista High-Sensitivity Troponin I (TNIH) Assay is MMI.

Related Clinical Trials

NCT05078853 Thyroglobulin Point of Care Assay for Rapid Detection of Metastatic Differentiated Thyroid Carcinoma COMPLETED NCT04624880 COMT Activity and Hypnotizability COMPLETED

Other Devices by Siemens Healthcare Diagnostics, Inc.

K161494Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL) K161964ADVIA Centaur HAV IgM Assay K160724ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator K151986ADVA Centaur Testosterone II (TSTII), ADVA Centaur Testosterone II (TSTII) Master Curve Material, ADVIA Centaur SHBG, ADVIA Centaur SHBG Calibrator, ADVIA Centaur SHBG Master Curve Material K160647IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4 K160202Trinidad CH Vancomycin (Vanc), Trinidad CH Drug 3 Calibrator (DRUG3 CAL)

View all 71 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.

↑