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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Counter, Cell, Automated (Particle Counter)
510(k) Number K152776
Device Name Glocyte Automated Cell Counter System
Applicant
Advanced Instruments, Inc.
2 Technology Way
Norwood,  MA  02062
Applicant Contact Robert Mello
Correspondent
Advanced Instruments, Inc.
2 Technology Way
Norwood,  MA  02062
Correspondent Contact Robert Mello
Regulation Number864.5200
Classification Product Code
GKL  
Subsequent Product Code
JPK  
Date Received09/25/2015
Decision Date 05/27/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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