FDA 510(k) Application Details - K183205

Device Classification Name	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use   More FDA Info for this Device
510(K) Number	K183205
Device Name	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Applicant	EmCyte Corporation 4331 Veronica S. Shoemaker Blvd, Suite 4 Fort Myers, FL 33916 US Other 510(k) Applications for this Company
Contact	Patrick Pennie Other 510(k) Applications for this Contact
Regulation Number	862.2050   More FDA Info for this Regulation Number
Classification Product Code	JQC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/19/2018
Decision Date	05/30/2019
Decision	SESU - SE - WITH LIMITATIONS
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review