Glocyte Automated Cell Counter System— 510(k) K152776

Clearance details

Applicant

Advanced Instruments, Inc.

Product code

Code GKL

Device class

Class 2

Regulation

21 CFR 864.5200

Advisory panel

Hematology

Date received

2015-09-25

Decision date

2016-05-27

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Norwood, MA, US

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• Z-0640-2019 — GloCyte RBC Reagent - Product Usage: The GloCyte Automated Cell Counter System is intended for use by trained healthcare professionals in clinical laboratories to provide quantitative determination of fluorescence labeled total nucleated cells and erythrocytes in cerebrospinal fluid collected from adult and pediatric patients. The GloCyte Low and High Level Controls are assayed hematology controls designed to monitor the performance of the GloCyte Automated Cell Counter System. Assayed parameters include total nucleated cells and erythrocytes.Class II·Terminated·Advanced Instruments, LLC·20180207

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K152776.