FDA 510(k) Application Details - K121445

Device Classification Name	More FDA Info for this Device
510(K) Number	K121445
Device Name	TETRACHROME REAGENTS AND TETRACXP SYSTEM
Applicant	BECKMAN COULTER, INC. 11800 SW 147TH AVE. M/S 31-B06 MIAMI, FL 33196-2500 US Other 510(k) Applications for this Company
Contact	NANCY NADLER Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OYE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/15/2012
Decision Date	07/26/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review