FDA 510(k)

Glocyte 自动细胞计数系统

K号: K152776 · 2016-05-27

决定日期2016-05-27

产品代码GKL

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器械摘要

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.

常见问题

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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