FDA.reportPublic FDA data

510(k) K030950

Device
VIDAS TROPONIN I (TNI), MODEL 30 445
Applicant
bioMerieux, Inc.
510(k) number
K030950
Product code
MMI
Decision
Substantially Equivalent (SESE)
Decision date
2003-06-16
Date received
2003-03-26
Regulation
862.1215
Classification name
Immunoassay Method, Troponin Subunit
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Nancy Weaver
Address
595 Anglum Rd. Hazelwood MO US 63042 63042

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MMI#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252393VITROS Immunodiagnostic Products hs Troponin I Reagent PackOrtho-Clinical Diagnostics, Inc.2025-10-29
K243483Access hsTnIBeckman Coulter, Inc.2025-08-01
K242870Access hsTnIBeckman Coulter, Inc.2025-06-16
K240984i-STAT hs-TnI cartridge with the i-STAT 1 SystemAbbott Point of Care, Inc.2025-01-03
K241165Atellica® IM High-Sensitivity Troponin I (TnIH)Siemens Healthcare Diagnostics, Inc.2024-07-25
K231974PATHFAST®hs-cTnI-IIPhc Corporation2024-03-20
K222881Access hsTnIBeckman Coulter, Inc.2023-12-18
K230648Access hsTnIBeckman Coulter, Inc.2023-12-04
K230994Alinity i STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division2023-05-04
K202525Alinity i STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division2022-05-19
K201441Elecsys Troponin T Gen 5Roche Diagnostics2021-09-21
K191595ARCHITECT STAT High Sensitivity Troponin-IAbbott Laboratories Diagnostics Division2019-09-13
K190675Dimension EXL High-Sensitivity Troponin I (TNIH) AssaySiemens Healthcare Diagnostics, Inc.2019-05-17
K182225Dimension Vista High-Sensitivity Troponin I (TNIH) AssaySiemens Healthcare Diagnostics, Inc.2019-03-04
K171566Atellica IM High-Sensitivity Troponin I (TNIH)Siemens Healthcare Diagnostics, Inc.2018-07-19