FDA 510(k)

Assay IMMULITE 2000 TSI, Material de Verificación de Calibración IMMULITE 2000 TSI

N.º K: K152061 · 2016-03-03

SolicitanteSiemens Healthcare Diagnostics, Inc.

Fecha de decisión2016-03-03

Código de productoJZO

Comité asesorIM

DecisiónSubstantially Equivalent

Resumen del dispositivo

IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material 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 2016-03-03 under 510(k) number K152061. The device is classified under product code JZO. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material?

IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material is a medical device that received FDA 510(k) clearance on 2016-03-03. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K152061.

When did IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material receive FDA 510(k) clearance?

IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material received FDA 510(k) clearance on 2016-03-03, under 510(k) number K152061.

Who is the listed applicant for IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material?

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 IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material?

The FDA product code for IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material is JZO.

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Fuente oficial

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