FDA 510(k)

cobas m 511 integrated hematology analyzer

N.º K: K171655 · 2018-03-02

SolicitanteRoche Diagnostics Hematology, Inc.

Fecha de decisión2018-03-02

Código de productoGKZ

Comité asesorHE

DecisiónSubstantially Equivalent

Resumen del dispositivo

cobas m 511 integrated hematology analyzer is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Hematology, Inc.. It received FDA 510(k) clearance on 2018-03-02 under 510(k) number K171655. The device is classified under product code GKZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the cobas m 511 integrated hematology analyzer?

cobas m 511 integrated hematology analyzer is a medical device that received FDA 510(k) clearance on 2018-03-02. The listed applicant is Roche Diagnostics Hematology, Inc.. The 510(k) number is K171655.

When did cobas m 511 integrated hematology analyzer receive FDA 510(k) clearance?

cobas m 511 integrated hematology analyzer received FDA 510(k) clearance on 2018-03-02, under 510(k) number K171655.

Who is the listed applicant for cobas m 511 integrated hematology analyzer?

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

What is the FDA product code for cobas m 511 integrated hematology analyzer?

The FDA product code for cobas m 511 integrated hematology analyzer is GKZ.

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Fuente oficial

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