FDA 510(k) Application Details - DEN160047

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN160047
Device Name	ClearLLab T1, ClearLLab T2, ClearLLab B1, ClearLLab B2, ClearLLab M
Applicant	Beckman Coulter 11800 SW 147th Ave Miami, FL 33196 US Other 510(k) Applications for this Company
Contact	Anthony Dennis Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PWD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/03/2016
Decision Date	06/29/2017
Decision	DENG -
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review