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FDA 510(k)

Glocyte Automated Cell Counter System

N.º K: K152776 · 2016-05-27

SolicitanteAdvanced Instruments, Inc.
Fecha de decisión2016-05-27
Código de productoGKL
Comité asesorHE
DecisiónSubstantially Equivalent

Resumen del dispositivo

Glocyte Automated Cell Counter System is the device name listed in this FDA 510(k) record. The listed applicant is Advanced Instruments, Inc.. It received FDA 510(k) clearance on 2016-05-27 under 510(k) number K152776. The device is classified under product code GKL. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Glocyte Automated Cell Counter System?

Glocyte Automated Cell Counter System is a medical device that received FDA 510(k) clearance on 2016-05-27. The listed applicant is Advanced Instruments, Inc.. The 510(k) number is K152776.

When did Glocyte Automated Cell Counter System receive FDA 510(k) clearance?

Glocyte Automated Cell Counter System received FDA 510(k) clearance on 2016-05-27, under 510(k) number K152776.

Who is the listed applicant for Glocyte Automated Cell Counter System?

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

What is the FDA product code for Glocyte Automated Cell Counter System?

The FDA product code for Glocyte Automated Cell Counter System is GKL.

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Fuente oficial

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