Cleared Traditional

Glocyte Automated Cell Counter System

K152776 · Advanced Instruments, Inc. · Hematology
May 2016
Decision
245d
Days
Class 2
Risk

About This 510(k) Submission

K152776 is an FDA 510(k) clearance for the Glocyte Automated Cell Counter System, a Counter, Cell, Automated (particle Counter) (Class II — Special Controls, product code GKL), submitted by Advanced Instruments, Inc. (Norwood, US). The FDA issued a Cleared decision on May 27, 2016, 245 days after receiving the submission on September 25, 2015. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5200.

Submission Details

510(k) Number K152776 FDA.gov
FDA Decision Cleared SESE
Date Received September 25, 2015
Decision Date May 27, 2016
Days to Decision 245 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GKL — Counter, Cell, Automated (particle Counter)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5200

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