FDA 510(k) Application Details - K052925

Device Classification Name	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use   More FDA Info for this Device
510(K) Number	K052925
Device Name	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use
Applicant	HARVEST TECHNOLOGIES, CORP. 40 GRISSOM RD PLYMOUTH, MA 02360 US Other 510(k) Applications for this Company
Contact	JOHN D BONASERA 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	10/18/2005
Decision Date	01/04/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review