FDA 510(k)

VITROS Immunodiagnostic Products hs Troponin I Reagent Pack

N.º K: K252393 · 2025-10-29

SolicitanteOrtho-Clinical Diagnostics, Inc.

Fecha de decisión2025-10-29

Código de productoMMI

Comité asesorCH

DecisiónSubstantially Equivalent

Resumen del dispositivo

VITROS Immunodiagnostic Products hs Troponin I Reagent Pack is the device name listed in this FDA 510(k) record. The listed applicant is Ortho-Clinical Diagnostics, Inc.. It received FDA 510(k) clearance on 2025-10-29 under 510(k) number K252393. The device is classified under product code MMI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the VITROS Immunodiagnostic Products hs Troponin I Reagent Pack?

VITROS Immunodiagnostic Products hs Troponin I Reagent Pack is a medical device that received FDA 510(k) clearance on 2025-10-29. The listed applicant is Ortho-Clinical Diagnostics, Inc.. The 510(k) number is K252393.

When did VITROS Immunodiagnostic Products hs Troponin I Reagent Pack receive FDA 510(k) clearance?

VITROS Immunodiagnostic Products hs Troponin I Reagent Pack received FDA 510(k) clearance on 2025-10-29, under 510(k) number K252393.

Who is the listed applicant for VITROS Immunodiagnostic Products hs Troponin I Reagent Pack?

The FDA 510(k) record lists Ortho-Clinical Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VITROS Immunodiagnostic Products hs Troponin I Reagent Pack?

The FDA product code for VITROS Immunodiagnostic Products hs Troponin I Reagent Pack is MMI.

Ensayos clínicos relacionados

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Otros registros que enlistan a Ortho-Clinical Diagnostics, Inc. como solicitante

K210858VITROS Chemistry Products PHBR Slides K191316VITROS XT Chemistry Products ALB-TP Slides K190807VITROS XT Chemistry Products TBIL-ALKP Slides K190520VITROS XT Chemistry Products GLU-Ca Slides K190490VITROS XT Chemistry Products TRIG-CHOL Slides K190326VITROS XT Chemistry Products UREA-CREA Slides

Ver todos los 11 dispositivos →

Dispositivos relacionados (Código: MMI)

K253051i-STAT hs-TnI cartridge with the i-STAT Alinity SystemAbbott Point of Care, 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.K231974PATHFAST®hs-cTnI-IIPhc Corporation

Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.