Alpha DX Analyzer 01-0100, Alpha DX Myo/Ck/Ck-Mb/Tni Cardiac Panel Test Kit 03-0001, Alpha DX Ck/Ck-Mb Panel Test Kit

FDA 510(k) K974839 · First Medical, Inc.

Substantially Equivalent

510(k) numberK974839

Submission

Device name
Alpha DX Analyzer 01-0100, Alpha DX Myo/Ck/Ck-Mb/Tni Cardiac Panel Test Kit 03-0001, Alpha DX Ck/Ck-Mb Panel Test Kit
Applicant
First Medical, Inc.
Mountain View, CA, US
Received
December 24, 1997
Decision date
February 4, 1998
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MMI – Immunoassay Method, Troponin Subunit
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1215
Specialty
Clinical Chemistry

Other 510(k)s with product code MMI

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K253051i-STAT hs-TnI cartridge with the i-STAT Alinity SystemMMI · Traditional Abbott Point of Care, Inc.06/11/2026SE
K252393VITROS Immunodiagnostic Products hs Troponin I Reagent PackMMI · Traditional Ortho-Clinical Diagnostics, Inc.10/29/2025SE
K243483Access hsTnIMMI · Traditional Beckman Coulter, Inc.08/01/2025SE
K242870Access hsTnIMMI · Traditional Beckman Coulter, Inc.06/16/2025SE
K240984i-STAT hs-TnI cartridge with the i-STAT 1 SystemMMI · Traditional Abbott Point of Care, Inc.01/03/2025SE
K241165Atellica® IM High-Sensitivity Troponin I (TnIH)MMI · Traditional Siemens Healthcare Diagnostics, Inc.07/25/2024SE
K231974PATHFAST®hs-cTnI-IIMMI · Traditional Phc Corporation03/20/2024SE
K222881Access hsTnIMMI · Traditional Beckman Coulter, Inc.12/18/2023SE
K230648Access hsTnIMMI · Traditional Beckman Coulter, Inc.12/04/2023SE
K230994Alinity i STAT High Sensitivity Troponin-IMMI · Special Abbott Laboratories Diagnostics Division05/04/2023SE

More from Abbott Laboratories Diagnostics Division

510(k)DeviceDecision
K014024Modification to Alpha DX SystemMMI · Special 12/18/2001SE
K013118Modification to Alpha DX SystemJHX · Special 10/15/2001SE
K010562Alpha DX SystemMMI · Special 03/13/2001SE

Questions and answers

When was Alpha DX Analyzer 01-0100, Alpha DX Myo/Ck/Ck-Mb/Tni Cardiac Panel Test Kit 03-0001, Alpha DX Ck/Ck-Mb Panel Test Kit cleared by the FDA?

Alpha DX Analyzer 01-0100, Alpha DX Myo/Ck/Ck-Mb/Tni Cardiac Panel Test Kit 03-0001, Alpha DX Ck/Ck-Mb Panel Test Kit (K974839) received a 510(k) decision of Substantially Equivalent on February 4, 1998, 42 days after the submission was received.

What is the product code of K974839?

The FDA product code is MMI – Immunoassay Method, Troponin Subunit, a Class II (moderate risk) device regulated under 21 CFR 862.1215.