FDA 510(k)

Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator

N.º K: K151529 · 2016-02-11

SolicitanteSiemens Healthcare Diagnostics, Inc.

Fecha de decisión2016-02-11

Código de productoCDZ

Comité asesorCH

DecisiónSubstantially Equivalent

Resumen del dispositivo

Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2016-02-11 under 510(k) number K151529. The device is classified under product code CDZ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator?

Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator is a medical device that received FDA 510(k) clearance on 2016-02-11. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K151529.

When did Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator receive FDA 510(k) clearance?

Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator received FDA 510(k) clearance on 2016-02-11, under 510(k) number K151529.

Who is the listed applicant for Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator?

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

What is the FDA product code for Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator?

The FDA product code for Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator is CDZ.

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Fuente oficial

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