FDA 510(k) Application Details - K152776

Device Classification Name	Counter, Cell, Automated (Particle Counter)   More FDA Info for this Device
510(K) Number	K152776
Device Name	Counter, Cell, Automated (Particle Counter)
Applicant	Advanced Instruments, Inc. 2 Technology Way Norwood, MA 02062 US Other 510(k) Applications for this Company
Contact	Robert Mello Other 510(k) Applications for this Contact
Regulation Number	864.5200   More FDA Info for this Regulation Number
Classification Product Code	GKL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/25/2015
Decision Date	05/27/2016
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review