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FDA 510(k)

Glocyte Automated Cell Counter System

K-Number: K152776 · 2016-05-27

ApplicantAdvanced Instruments, Inc.
Decision Date2016-05-27
Product CodeGKL
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by Advanced Instruments, Inc.. The 510(k) number is K152776.

When was Glocyte Automated Cell Counter System approved by the FDA?

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

What company makes Glocyte Automated Cell Counter System?

Glocyte Automated Cell Counter System is manufactured by Advanced Instruments, Inc..

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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Official Source

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